AYURVEDIC TONGUE CLEANER

K971025 · Calello Martinez P.C. · LCN · May 22, 1997 · Dental

Device Facts

• Record ID: K971025
• Device Name: AYURVEDIC TONGUE CLEANER
• Applicant: Calello Martinez P.C.
• Product Code: LCN · Dental
• Decision Date: May 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

The Ayurvedic Tongue Cleaner is a device used to remove food particles and debris from the tongue. It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.

Device Story

Ayurvedic Tongue Cleaner is a manual oral hygiene tool designed to remove food particles and debris from the tongue surface. Used by patients at home as an adjunct to standard brushing and flossing. Device functions mechanically via physical scraping of the tongue surface. Does not replace standard dental care. Benefits include improved oral hygiene through debris removal.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual, non-powered oral hygiene device. Materials and dimensions not specified in the provided documentation.

Indications for Use

Indicated for individuals seeking to remove food particles and debris from the tongue as a supplement to standard oral hygiene (brushing and flossing). No specific age or gender restrictions.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 22 1997

Veda Health Incorporated
C/O Antonio C. Martinez, II Esq
General Counsel to Veda Health Incorporated
Calello Martinez P.C.
675 Franklin Avenue
Nutley, New Jersey 07110-1209

Re: K971025
Trade Name: Ayurvedic Tongue Cleaner
Regulatory Class: Unclassified
Product Code: LCN
Dated: April 15, 1997
Received: April 21, 1997

Dear Mr. Martinez:

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 of the Act. The general controls provisions 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 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 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. Martinez

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,

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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Page 1 of 1

510(k) Number (if known): K971025

Device Name: Ayurvedic Tongue Cleaner

Indications For Use:

The Ayurvedic Tongue Cleaner is a device used to remove food particles and debris from the tongue.

It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.

(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 K971025

Prescription Use

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)