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.
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368 Plaque Pencil
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
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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.