This is kind of a silly one, but wanted to make 'pencils' using some kind of edible abrasives that users could scratch off their own plaque, especially at the top of their teeth by the gum.
In this slide contains introduction, types, anticaries, mouthwash etc..
Presented by: SHAIK GOUSE UL AZAM (Department of pharmaceutical analysis).RIPER, anantapur
Dental Equipments - We are manufacturer and suppliers of Dental Equipment, Dental Instruments Dental Products & Tools including Dental Chair, Dental Air Compressor, Ultra Sonic Dental Scaler, Dental Light Cure Unit, Jaw & Teeth Set and Dental Head Simulator Unit
In this slide contains introduction, types, anticaries, mouthwash etc..
Presented by: SHAIK GOUSE UL AZAM (Department of pharmaceutical analysis).RIPER, anantapur
Dental Equipments - We are manufacturer and suppliers of Dental Equipment, Dental Instruments Dental Products & Tools including Dental Chair, Dental Air Compressor, Ultra Sonic Dental Scaler, Dental Light Cure Unit, Jaw & Teeth Set and Dental Head Simulator Unit
Shield celebrate the world oral health day with calibration of PDA at Altamash Institute Of Dental Medicine. In this occasion Dr Aakifa Javed, 3rd year BDS student, presented "Methods to control plaque formation in the oral cavity & proper brushing technique(bass technique).
Dental probe and explorer are regular diagnostic tools with numerous dental applications. The purpose of these tools may seem identical, but it is important to study them individually.
With Piezomed, users can concentrate on the surgical procedure with a piece o...A-dec Australia
Piezomed from W&H facilitates the work of the oral surgeon with its innovative ultrasound technology. High-frequency microvibrations allow cutting with incredible precision and in addition, with the so called cavitation effect, you can also ensure an almost blood-free surgical site.
Atraumatic restorative treatment (art) for tooth
Atraumatic Restorative Treatment (ART), is based on removing decalcified tooth tissue using only hand instruments and restoring the cavity with an adhesive filling material.
A minimally invasive approach to both prevent dental carious lesions and stop its further progression
Cleaning of dentures by different agents and their adverse effects explained.
Various types of denture adhesives used by clinicians and their proper use is mentioned.
Precision attachments in prosthodontics/ orthodontics short term coursesIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
So you want to build an app? The HeirList Dev kickoff deckChief Innovation
The starting deck for our mobile application development project. This, along with a detailed Excel file, were the starting documents used for the development of the HeirList mobile application. We are posting this so people who aspire to have an app built can see some of the things they need to think about when planning it out. We hoped 3-4 months, thought it could go over 5. Didn't think it could take 6 and rejected people who told us that. It took THIRTEEN months. Insanely complicated, from back-end, to testing to fixing bugs and email interfaces. Hoping that this helps people and people forward it around. Our structure wasn't perfect, but shows some of the elements to think about, consider and decide. And this was the 'starting' deck, we had dozens of more pages of stuff after this, along with a final count of about 625 different use cases for testing! Think this deck is a little under 100 pages.
Had created this list to give to people so they could fix their own resumes. Was redoing close to 50-100 a year for free, got tired of telling the same things to different people. Now when people ask me for help, pass this to them, tell them to fix these and not get back to me until they do. Keeps many of them from coming back and asking more of my time. A WIN!
Shield celebrate the world oral health day with calibration of PDA at Altamash Institute Of Dental Medicine. In this occasion Dr Aakifa Javed, 3rd year BDS student, presented "Methods to control plaque formation in the oral cavity & proper brushing technique(bass technique).
Dental probe and explorer are regular diagnostic tools with numerous dental applications. The purpose of these tools may seem identical, but it is important to study them individually.
With Piezomed, users can concentrate on the surgical procedure with a piece o...A-dec Australia
Piezomed from W&H facilitates the work of the oral surgeon with its innovative ultrasound technology. High-frequency microvibrations allow cutting with incredible precision and in addition, with the so called cavitation effect, you can also ensure an almost blood-free surgical site.
Atraumatic restorative treatment (art) for tooth
Atraumatic Restorative Treatment (ART), is based on removing decalcified tooth tissue using only hand instruments and restoring the cavity with an adhesive filling material.
A minimally invasive approach to both prevent dental carious lesions and stop its further progression
Cleaning of dentures by different agents and their adverse effects explained.
Various types of denture adhesives used by clinicians and their proper use is mentioned.
Precision attachments in prosthodontics/ orthodontics short term coursesIndian dental academy
Indian Dental Academy: will be one of the most relevant and exciting training center with best faculty and flexible training programs for dental professionals who wish to advance in their dental practice,Offers certified courses in Dental implants,Orthodontics,Endodontics,Cosmetic Dentistry, Prosthetic Dentistry, Periodontics and General Dentistry.
So you want to build an app? The HeirList Dev kickoff deckChief Innovation
The starting deck for our mobile application development project. This, along with a detailed Excel file, were the starting documents used for the development of the HeirList mobile application. We are posting this so people who aspire to have an app built can see some of the things they need to think about when planning it out. We hoped 3-4 months, thought it could go over 5. Didn't think it could take 6 and rejected people who told us that. It took THIRTEEN months. Insanely complicated, from back-end, to testing to fixing bugs and email interfaces. Hoping that this helps people and people forward it around. Our structure wasn't perfect, but shows some of the elements to think about, consider and decide. And this was the 'starting' deck, we had dozens of more pages of stuff after this, along with a final count of about 625 different use cases for testing! Think this deck is a little under 100 pages.
Had created this list to give to people so they could fix their own resumes. Was redoing close to 50-100 a year for free, got tired of telling the same things to different people. Now when people ask me for help, pass this to them, tell them to fix these and not get back to me until they do. Keeps many of them from coming back and asking more of my time. A WIN!
523 Business Plan Example - Long Version - JobSerfChief Innovation
Was on my other SlideShare site, but wanted to put it here so people could see an example of a detailed business plan. Some people will say you don't need this, but most investors will not. Mostly just want to show the structure, flow and sections. In the end, we never did a raise on this, but had 2 rounds earlier without it. Took a LONG time to do. Thanks Darvin.
Attached are about 10 from my Philanthropic List that I pitched to Steve Ivy after we had lunch about 5 years ago. Had a business idea on the front. Great guy, and if you ever have paintings or art over a million bucks, Heritage Auctions is who you should call. I never do though :(
One of my bosses at Frito remarked 'any ideas regarding chips & pretzels we've already thought of', to which I clarified 'so you are telling me that no one could think of anything you guys haven't already?' Yes, that was what he meant. Too funny. So this wasn't part of my job, and 15 years later pretty sure they didn't do it. Still was a good idea. Goal was to make the guys doing the stocking lives' easier so they could pull older bags to front to reduce stales.
Seeing the difficulty in passing around Buying & Selling deals, I created a network (mostly of people I knew) with a whole structure to exchange deals. Brokers joined as they would represent their clients and still added value. Went on for a year or two, but since it was a total freebie on my part, it never really got pushed. Philip Gay and I discussed doing brokering together, but he went off to be CEO of Grille Concepts back in Southern California, and I really didn't want this to be my 'job' was just trying to help people and found it interesting.
Wrote this up as I think it is a good and doable idea. Here in Dallas almost all companies are having staffing shortages. Homeless people have multiple issues in engaging to make money, with having a fixed address and bank are just some of them. The idea was to create an App to coordinate Temporary Staffing assignments, supported by transportation to work sites (this exists already in Dallas). Need to find an HRIS system to convert, or coders to build this, then a city to execute it. I have no coding skills, and have too much going on, but have been kicking this around to see if anyone is interested.
This was a good idea because people were working on it back then, and think it's been close to perfected. Real simple, have a Speech to Text Engine on the other side of phone lines, let people talk and then have the output sent to them via email or stored somewhere. I had done a deal for Harman back in 1995 looking at related technologies and wondered why this hadn't been done by the time I thought of it, think late 1990s.
I had created an event for ISM (Institute of Supply Management). Not on my list, but had a deck so am putting it out anyways. With better marketing from a group, this could be a good idea.
This is still a good idea, but there are some similar projects out now. Think this is 2002 or so. Very simple concept, make some basic alarms that can trigger a pre-stored alert via the cellphone network. Example, someone trips up a door in your remote cabin, device calls in with a code, that triggers a pre-written text or recorded voicemail by you and gets sent 'someone has opened your cabin's door'. You can decide to call police after that. I did a ton of research on this, as you can see in the deck. Dropped it as the dollars required would have been massive to get it off the ground.
This was around 2001 or so, still a decent idea. Concept is that you have a card with all of your information, along with possible body shop or other advertisements, that people can quickly/easily exchange in an accident. Advertisers would pay for the cards, and then maybe distributed by insurance companies. Was on a patent kick after my first, never came close to filing on this one, but here was some of the start. Not sure if I have other decks, didn't see them, but thought I did.
Deck on my firm, Chief Innovation. Focus of work is Supply Chain, Operations & Strategy consulting, but chose name as an umbrella for innovation pursuits, both start-up and charity.
Provisional Patent Framework - Do It Yourself DIYChief Innovation
I made a sheet for myself as I knew I'd be cranking out a ton of patents (done 9 filings myself as of 2019). This is just a Word document for the aspiring inventor to get started and avoid an expensive patent attorney for as long as they can (get one for the Claims piece)
This is another one from around 2001, and now is being done by multiple people, including Google. Idea was simple, instead of passing big files, pass people links to which they can download them. Basic stuff 18 years later. My $550 (in 2001) per hour Haynes & Boone Partner taught me a lot about working with expensive attorneys from doing this. The deck wasn't finished, and still had lots of filler pages. with blanks, so forgive me for posting those.
Not sure why it took companies so long, I pitched this to Siebel in 2001, and seemed obvious. These are now standard, and don't pretend I was the only one who ever thought of it, but Siebel had to blow me off, as like many big companies, they cannot 'accept' ideas without IP from the outside. Glad to see these are prevalent now 18 years later.
I almost did this twice for my own companies. It is a hybrid of speed dating and mentoring. Goal is to get kids who aren't from the wealthy areas to meet MBAs and Law Students over dinner, just to hear their paths and stories. Very inexpensive, and not an imposition for the students either. Uber makes the transportation issue with parents go away as well. Inexpensive way to open up the world of possibilities to those who aren't already immersed in it.
Details of the Retired Teacher Gratitude Project. We welcome any ideas or suggestions of possible Pension Managers. We do not underestimate how hard it will be to get them to take this on, so no worries if you were going to warn us. Trust me, we know! But we loved our teachers, so we are going to try!
Give Retired Teachers billions of dollars without a single tax dollar. (Loading in coming week)
Didn't realize SlideShare changed the rules to Upload, sorry about that. The deck is in another SlideShare in this account.
Discover the innovative and creative projects that highlight my journey throu...dylandmeas
Discover the innovative and creative projects that highlight my journey through Full Sail University. Below, you’ll find a collection of my work showcasing my skills and expertise in digital marketing, event planning, and media production.
Enterprise Excellence is Inclusive Excellence.pdfKaiNexus
Enterprise excellence and inclusive excellence are closely linked, and real-world challenges have shown that both are essential to the success of any organization. To achieve enterprise excellence, organizations must focus on improving their operations and processes while creating an inclusive environment that engages everyone. In this interactive session, the facilitator will highlight commonly established business practices and how they limit our ability to engage everyone every day. More importantly, though, participants will likely gain increased awareness of what we can do differently to maximize enterprise excellence through deliberate inclusion.
What is Enterprise Excellence?
Enterprise Excellence is a holistic approach that's aimed at achieving world-class performance across all aspects of the organization.
What might I learn?
A way to engage all in creating Inclusive Excellence. Lessons from the US military and their parallels to the story of Harry Potter. How belt systems and CI teams can destroy inclusive practices. How leadership language invites people to the party. There are three things leaders can do to engage everyone every day: maximizing psychological safety to create environments where folks learn, contribute, and challenge the status quo.
Who might benefit? Anyone and everyone leading folks from the shop floor to top floor.
Dr. William Harvey is a seasoned Operations Leader with extensive experience in chemical processing, manufacturing, and operations management. At Michelman, he currently oversees multiple sites, leading teams in strategic planning and coaching/practicing continuous improvement. William is set to start his eighth year of teaching at the University of Cincinnati where he teaches marketing, finance, and management. William holds various certifications in change management, quality, leadership, operational excellence, team building, and DiSC, among others.
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Affordable Stationery Printing Services in Jaipur | Navpack n PrintNavpack & Print
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Kseniya Leshchenko: Shared development support service model as the way to ma...Lviv Startup Club
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Digital Transformation and IT Strategy Toolkit and TemplatesAurelien Domont, MBA
This Digital Transformation and IT Strategy Toolkit was created by ex-McKinsey, Deloitte and BCG Management Consultants, after more than 5,000 hours of work. It is considered the world's best & most comprehensive Digital Transformation and IT Strategy Toolkit. It includes all the Frameworks, Best Practices & Templates required to successfully undertake the Digital Transformation of your organization and define a robust IT Strategy.
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This PowerPoint presentation is only a small preview of our Toolkits. For more details, visit www.domontconsulting.com
Premium MEAN Stack Development Solutions for Modern BusinessesSynapseIndia
Stay ahead of the curve with our premium MEAN Stack Development Solutions. Our expert developers utilize MongoDB, Express.js, AngularJS, and Node.js to create modern and responsive web applications. Trust us for cutting-edge solutions that drive your business growth and success.
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[Note: This is a partial preview. To download this presentation, visit:
https://www.oeconsulting.com.sg/training-presentations]
Sustainability has become an increasingly critical topic as the world recognizes the need to protect our planet and its resources for future generations. Sustainability means meeting our current needs without compromising the ability of future generations to meet theirs. It involves long-term planning and consideration of the consequences of our actions. The goal is to create strategies that ensure the long-term viability of People, Planet, and Profit.
Leading companies such as Nike, Toyota, and Siemens are prioritizing sustainable innovation in their business models, setting an example for others to follow. In this Sustainability training presentation, you will learn key concepts, principles, and practices of sustainability applicable across industries. This training aims to create awareness and educate employees, senior executives, consultants, and other key stakeholders, including investors, policymakers, and supply chain partners, on the importance and implementation of sustainability.
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1. Develop a comprehensive understanding of the fundamental principles and concepts that form the foundation of sustainability within corporate environments.
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1. Introduction and Key Concepts of Sustainability
2. Principles and Practices of Sustainability
3. Measures and Reporting in Sustainability
4. Sustainability Implementation & Best Practices
To download the complete presentation, visit: https://www.oeconsulting.com.sg/training-presentations
Business Valuation Principles for EntrepreneursBen Wann
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Tata Group Dials Taiwan for Its Chipmaking Ambition in Gujarat’s DholeraAvirahi City Dholera
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1. Plaque Pencil
------------------
FDA, FDA, FDA
National average for teeth cleaning is $85 (CNN)
$60 billion spent in 2000 on Oral Hygiene
What could I patent?
Machine
Article of manufacture (lead)
Composition
NEED TO ASK JACK
=================================================
Background
Bristle brushes, flossing, metal pics and mirrors, sonic, irrigators,
brushs including electric think toothpick or anything stand alone, outside
support
or inside support
Mechanical removal using metal pics, rubber or floss
Chemical - paste to remove plaque and tartar
Specification
What is it?
Mechanical device to remove plauqe, tartar and other undesired
materials from teeth and vincinity which is softer then tooth
material and relies on abrasives and mechanical removal to reduce
damage to teeth, gums and other areas of the mouth.
Components
Lead, Handle/pencil
Best Mode
Not sure yet
Operation
Load, manipulate in mouth, teeth surface, perimeter or gums, reload
Variants
Material, type of pencil
Uses
Plaque, tartar, people, animals
Benefits
Remove, safer, low cost, promo product, portable, more confidence,
reusable
Can use for children, animals, less pain, damage to teeth and gums
Claims
Hand device using abrasive or degradable to mechanically remove
unwanted material, plaque, tartar or other, from teeth & surrounding area
---------------------------------------------------------------------
Get all Mfgers of teeth stuff
Build a short pitch
Need material research to be done
Need to understand FDA issues
Look at wheels they use in offices, same kind of materials, grisely
Look at all inventions already filed or available
Plaque builds on tartar, needs to get scraped off
Krogers - toothpaste, scraping
How to get it sharp
Leave it as dull cylinder - does it need to be sharp
Have a pencil type sharperner
Have a knife type sharpener
What angle to have? Thickness of lead?
Ask dentists, look at instruments
Think of:
What material to be the 'lead'
Mouth wash, whitener, edible, abrasive, calcium......
2. Should it be porous for better 'scrapping'
Need to balance getting plaque off and not hurting teeth
What material to be the 'wood'
File or unrap (lean towards unrap)
How to make it?
Types of pencils - wood, cartridge (elementary school), mechanical
Either need to get the lead to top or bring top down (sharpening)
Pencils
Common - Use, wood
Cartridge or cap - multiple that can be stuck on end
Mechanical - twist, pull or spring/pump
grease and eraser pencils, wind/wrap
Look at eraser pencils, and all pencil variants like lead and plastic leads
wood pencils
mechanical pencils
elementary ones, cannot find any
lead holders, larger, could be of interest
Lead
Abrasive
Hard, but Soft enough not to damage teeth
Legal issues, people cutting their gums
Apply calcium or other beneficial stuff
Mouth wash or other protectant for tooth
Think of cutting tool materials, collapse at certain hardness
Edible
Whitener
Smell
Beneficial to gums
Anti-bleeding
Bacteria
Soluble in water
Abrasive
Can get underneath gum
existing is .5mm or 2.0mm
should be harder then plaque, softer then teeth
Promotional Potential
Dental clinics, companies or dentists
Toothpastes, Mouthwashes
Anyone promoting good dental health, some foods
PATENT
-----------------
Background
Metal scrappers which strip away the tooth,
cause discomfort and also reduce usage by
consumers due to fear of damaging. Many consumers
wait for the dentist or a hygenist to perform this.
Other options are chemical based applied by brushing which are
effective, but do not acheive complete elimination.
Field of Invention
Dental device for removing plaque or other matter
stuck to a tooth
3. FDA
===========================================================================
Which Product Classification is it?
Sec. 872.6010 Abrasive device and accessories.
Sec. 872.6030 Oral cavity abrasive polishing agent.
Sec. 872.6650 Massaging pick or tip for oral hygiene.
AGENT, POLISHING, ABRASIVE, ORAL CAVITY
Oral cavity abrasive polishing agent
DISK, ABRASIVE
Abrasive device and accessories
ERASER, DENTAL STAIN, MAU
INSTRUMENT, DIAMOND, DENTAL, EMP
POINT, ABRASIVE, EHL
Abrasive device and accessories
Dental diamond instrument, DZP
Massaging pick or tip for oral hygiene, JEW
Abrasive device and accessories, EJQ
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?
FR=872.6010
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR872.6010]
[Page 332]
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND
HUMAN
SERVICES (CONTINUED)
PART 872--DENTAL DEVICES--Table of Contents
Subpart G--Miscellaneous Devices
Sec. 872.6010 Abrasive device and accessories.
(a) Identification. An abrasive device and accessories is a
device
constructed of various abrasives, such as diamond chips, that are
glued
to shellac-based paper. The device is intended to remove excessive
restorative materials, such as gold, and to smooth rough surfaces
from
oral restorations, such as crowns. The device is attached to a
shank
that is held by a handpiece. The device includes the abrasive
disk,
4. guard for an abrasive disk, abrasive point, polishing agent strip,
and
polishing wheel.
(b) Classification. Class I (general controls). The device is
exempt
from the premarket notification procedures in subpart E of part
807 of
this chapter subject to the limitations in Sec. 872.9. If the
device is
not labeled or otherwise represented as sterile, it is exempt from
the
current good manufacturing practice regulations in part 820 of
this
chapter, with the exception of Sec. 820.180, with respect to
general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13830, Apr. 5,
1989; 66
FR 38799, July 25, 2001]
---------------------------------------------------------------------------
PART 872--DENTAL DEVICES--Table of Contents
Subpart G--Miscellaneous Devices
Sec. 872.6030 Oral cavity abrasive polishing agent.
(a) Identification. An oral cavity abrasive polishing agent
is a
device in paste or powder form that contains an abrasive material,
such
as silica pumice, intended to remove debris from the teeth. The
abrasive
polish is applied to the teeth by a handpiece attachment
(prophylaxis
cup).
(b) Classification. Class I (general controls). The device is
exempt
from the premarket notification procedures in subpart E of part
807 of
this chapter subject to the limitations in Sec. 872.9.
[52 FR 30097, Aug. 12, 1987, as amended at 59 FR 63009, Dec. 7,
1994; 66
FR 38799, July 25, 2001]
[[Page 333]]
--------------------------------------------------------------------------------
--
PART 872--DENTAL DEVICES--Table of Contents
Subpart G--Miscellaneous Devices
Sec. 872.6650 Massaging pick or tip for oral hygiene.
(a) Identification. A massaging pick or tip for oral hygiene
is a
rigid, pointed device intended to be used manually to stimulate
and
massage the gums to promote good periodontal (gum) condition.
5. (b) Classification. Class I (general controls). The device is
exempt
from the premarket notification procedures in subpart E of part
807 of
this chapter subject to the limitations in Sec. 872.9. If the
device is
not labeled or otherwise represented as sterile, it is exempt from
the
current good manufacturing practice regulations in part 820 of
this
chapter, with the exception of Sec. 820.180, with respect to
general
requirements concerning records, and Sec. 820.198, with respect to
complaint files.
[52 FR 30097, Aug. 12, 1987, as amended at 54 FR 13831, Apr. 5,
1989; 66
FR 38800, July 25, 2001]
---------------------------------------------------------------
Serves Dallas, Fort Worth, north and west Texas, and all of Oklahoma.
Maria Velasco (214) 253-5205
mvelasco@ora.fda.gov
Helen Monda (214) 253-5206
hmonda@ora.fda.gov
Food and Drug Administration
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3145
FAX (214) 253-5318
------------------------------------------------------------------------
Device
AGENT, POLISHING, ABRASIVE,
ORAL CAVITY
Device Description
Oral cavity abrasive polishing
agent
Medical Specialty
Dental
Product Code
EJR
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6030
FDA has exempted almost all class I devices
(with the exception of Reserved
Devices) from the premarket notification
requirement, including those devices that
were exempted by final regulation published in
the Federal Registers of December
7, 1994, and January 16, 1996. It is important
to confirm the exempt status and any
limitations that apply with 21 CFR Parts 862-
892. Limitations of device exemptions
are covered under 21 CFR xxx.9, where xxx refers
to Parts 862-892.
6. If a manufacturer's device falls into a generic
category of exempted class I devices
as defined in 21 CFR Parts 862-892, a premarket
notification application and FDA
clearance is not required before marketing the
device in the U.S. However, these
manufacturers are required to register their
establishment by submitting Form FDA
2891, "Initial Registration of Device
Establishment," and list the generic category or
classification name of the device by submitting
Form FDA 2892, "Device Listing."
--------------------------------------------------------------------------------
---------------------------
Device
DISK, ABRASIVE
Device Description
Abrasive device and
accessories
Medical Specialty
Dental
Product Code
EHJ
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6010
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.
FDA has exempted almost all class I devices
(with the exception of Reserved
Devices) from the premarket notification
requirement, including those devices that
were exempted by final regulation published in
the Federal Registers of December
7, 1994, and January 16, 1996. It is important
to confirm the exempt status and any
limitations that apply with 21 CFR Parts 862-
892. Limitations of device exemptions
are covered under 21 CFR xxx.9, where xxx refers
to Parts 862-892.
If a manufacturer's device falls into a generic
category of exempted class I devices
as defined in 21 CFR Parts 862-892, a premarket
notification application and FDA
clearance is not required before marketing the
device in the U.S. However, these
manufacturers are required to register their
establishment by submitting Form FDA
2891, "Initial Registration of Device
Establishment," and list the generic category or
classification name of the device by submitting
Form FDA 2892, "Device Listing."
7. --------------------------------------------------------------------------------
------------
Product Classification Database
Device
ERASER, DENTAL STAIN
Medical Specialty
Dental
Product Code
MAU
510(k) Exempt?
No
Device
INSTRUMENT, DIAMOND, DENTAL
Device Description
Dental diamond instrument
Medical Specialty
Dental
Product Code
DZP
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.4535
FDA has exempted almost all class I devices
(with the exception of Reserved
Devices) from the premarket notification
requirement, including those devices that
were exempted by final regulation published in
the Federal Registers of December
7, 1994, and January 16, 1996. It is important
to confirm the exempt status and any
limitations that apply with 21 CFR Parts 862-
892. Limitations of device exemptions
are covered under 21 CFR xxx.9, where xxx refers
to Parts 862-892.
If a manufacturer's device falls into a generic
category of exempted class I devices
as defined in 21 CFR Parts 862-892, a premarket
notification application and FDA
clearance is not required before marketing the
device in the U.S. However, these
manufacturers are required to register their
establishment by submitting Form FDA
2891, "Initial Registration of Device
Establishment," and list the generic category or
classification name of the device by submitting
Form FDA 2892, "Device Listing."
Device
MARKER, PERIODONTIC
Device Description
Dental hand instrument
Medical Specialty
Dental
Product Code
EMP
Device Class
8. 1
510(k) Exempt?
Yes
Regulation Number
872.4565
Device
PICK, MASSAGING
Device Description
Massaging pick or tip for
oral hygiene
Medical Specialty
Dental
Product Code
JET
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6650
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.
Device
POINT, ABRASIVE
Device Description
Abrasive device and
accessories
Medical Specialty
Dental
Product Code
EHL
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6010
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.
Device
TIP, RUBBER, ORAL HYGIENE
Device Description
Massaging pick or tip for
oral hygiene
Medical Specialty
Dental
Product Code
JEW
9. Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6650
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.
Device
WHEEL, POLISHING AGENT
Device Description
Abrasive device and
accessories
Medical Specialty
Dental
Product Code
EJQ
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6010
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.
10. Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6650
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.
Device
WHEEL, POLISHING AGENT
Device Description
Abrasive device and
accessories
Medical Specialty
Dental
Product Code
EJQ
Device Class
1
510(k) Exempt?
Yes
Regulation Number
872.6010
IMPORTANT NOTE: This device is also exempted
from the GMP
regulation, except for general requirements
concerning records (820.180) and
complaint files (820.198), as long as the device
is not labeled or otherwise
represented as sterile.