BREATHTIQUE TONGUE SCRAPER

K983087 · Custom Medical Arts, Inc. · LCN · Nov 18, 1998 · Dental

Device Facts

• Record ID: K983087
• Device Name: BREATHTIQUE TONGUE SCRAPER
• Applicant: Custom Medical Arts, Inc.
• Product Code: LCN · Dental
• Decision Date: Nov 18, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

The Breathtique Tongue Scraper is intended to be used to remove bacterial plaque and food debris from the surface of the tongue.

Device Story

Breathtique Tongue Scraper is a manual oral hygiene tool. Device functions by mechanical scraping of tongue surface to remove bacterial plaque and food debris. Used by patients in home setting for oral hygiene maintenance. Output is physical removal of debris; aids in reducing oral malodor and improving tongue cleanliness. No electronic, software, or algorithmic components.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Manual tongue scraping device. No energy source, software, or complex materials specified.

Indications for Use

Indicated for removal of bacterial plaque and food debris from the tongue surface. Intended for general population use.

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)

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, arranged in a stacked formation.

Nov 1 8 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Barry A. Goldberg President/Owner Custom Medical Arts, Incorporated 13882 North Kendall Drive Miami, Florida 33186

K983087 Re : Breathtique Tongue Scrapers Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: September 1, 1998 Received: September 3, 1998

Dear Mr. Goldberg:

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 be basyood of secting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

{1}------------------------------------------------

Page 2 - Mr. Goldberg

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 requlation (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

Timothy A. Ulatowski

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

Enclosure

{2}------------------------------------------------

510(k) Number (if known):

Device Name: Breathtique Tongue Scraper

Indications For Use:

The Breathtique Tongue Scraper is intended to be used to remove bacterial plaque and food debris from the surface of the tongue.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

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

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)