BREATHAID TONGUE SCRAPER

K981808 · Breathaid, LLC · LCN · Aug 11, 1998 · Dental

Device Facts

• Record ID: K981808
• Device Name: BREATHAID TONGUE SCRAPER
• Applicant: Breathaid, LLC
• Product Code: LCN · Dental
• Decision Date: Aug 11, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Device Story

The BreathAid Tongue Scraper is a manual oral hygiene device designed to remove debris and bacterial buildup from the surface of the tongue. It is intended for over-the-counter use by individuals to assist in oral hygiene maintenance and potentially reduce halitosis. The device is operated by the user through manual scraping motions across the tongue surface.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual oral hygiene device; non-powered; form factor designed for tongue surface scraping.

Regulatory Classification

Identification

A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized caduceus, a symbol of medicine and health. The caduceus is composed of three wavy lines that resemble a staff with two snakes coiled around it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG | | | 1998

BreathAid, LCC C/O Mr. J. Douglas Nunn, Jr. Nelson Mullins Riley & Scarborough, L.L.P. Keenan Building, Third Floor 1330 Lady Street P.O. Box 11070 (29211) Columbia, South Carolina 29201

Re : K981808 BreathAid Tonque Scraper Trade Name: Requlatory Class: Unclassified Product Code: LCN May 13, 1998 Dated: Received: May 21, 1998

Dear Mr. J. Douglas Nunn, Jr.:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. J. Douglas Nunn, Jr.

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

S. Autman for

Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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09:38

ODE DGRD

002

Page of

510(k) Number (if known): K981808

8301 827 4348

Device Name:

08/04/98

Indications For Use:

| Post-it® Fax Note | 7671 | Date | 8/5 | # of pages | 1 |
|-------------------|--------------|---------|------------|------------|---|
| To | MYRA BROWN | From | J.D. NUNN | | |
| Co./Dept. | | Co. | N&R+S | | |
| Phone # | | Phone # | | | |
| Fax # | 301-827-9349 | Fax # | 12732/0001 | | |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODDE)

Susan Rumsey

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 194 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Forman 1-2-96)