COPPER TONGUE SCRAPER

K980842 · Ontel Products Corp. · LCN · May 20, 1998 · Dental

Device Facts

• Record ID: K980842
• Device Name: COPPER TONGUE SCRAPER
• Applicant: Ontel Products Corp.
• Product Code: LCN · Dental
• Decision Date: May 20, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

This device is used to effectively remove bacteria and food debris from the surface of the tongue.

Device Story

Manual U-shaped tongue scraper constructed of copper; used to remove bacteria and food debris from tongue surface via gentle forward scraping motion. Intended for over-the-counter point-of-sale use by consumers. Copper material provides biostatic properties inhibiting bacterial growth on device surface. Device functions similarly to existing manual tongue cleaners; aids in oral hygiene maintenance.

Clinical Evidence

No clinical data. Effectiveness is based on the long history of safe use of tongue scrapers and the material properties of copper.

Technological Characteristics

Manual U-shaped scraper; material: copper; biostatic surface properties; non-powered; standalone device.

Indications for Use

Indicated for over-the-counter use by individuals to remove bacteria and food debris from the tongue surface to promote oral hygiene.

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.

Predicate Devices

• U.S. Dentek Sakool (K961574)
• Ooli-U Tongue Scraper (K970042)

Submission Summary (Full Text)

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MAY 20 1998

## 510(k) Summary

K980842

Submitter: Ontel Products Corporation 2 Daniel Road East Fairfield, NJ 07004

## Contact person: Mike K. Lakhiani

2 Daniel Road East Fairfield, NJ 07004 Phone: [phone] Phone: [phone] Fax:

Date Prepared: March 2nd, 1998

Name of Device: Copper Tongue Scraper

Common/Usual Name: Tongue Scraper / Tongue Cleaner

Classification Name: Scraper, Tongue (per 76LCN)

Predicate Device: U.S. Dentek Sakool (K961574) Ooli-U Tongue Scraper (K970042)

Description of Device: This device is a U-formed design made of Copper.

Intended Use: This device is used to effectively remove bacteria and food debris from the surface of the tongue.

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## 510(k) Summary

Technological Characteristics: The Copper Tongue Scraper and the mentioned predicate devices all work in a similar fashion. They are all manual devices used to remove bacteria and food debris from the surface of the tongue by a gentle forward scraping motion. The Copper Tongue Scraper is composed of copper. Copper is biostatic, which means bacteria will not grow on its surface.

Summary to support substantial equivalence: The Copper Tongue Scraper's effectiveness is based on the long history of safe use of tongue scrapers. The Copper Tongue Scraper has the same design principals as the predicate devices. The only difference is that Copper Tongue Scraper is made from copper. Based on the characteristics and health benefits of copper, it is a safe material to use for this device. Therefore the Copper Tongue Scraper is substantially equivalent to the predicate devices because it raises no additional issues of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 20 1998

Mr. Mike K. Lakhiani ·Vice President of Sales Ontel Products Corporation 2 Daniel Road East Fairfield, New Jersey 07004

Re : K980842 Copper Tongue Scraper Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: March 2, 1998 Received: March 4, 1998

Dear Mr. Lakhiani:

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 legally marketed predicate 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Lakhiani

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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 ere regulation enereica) 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.qov/cdrh/dsma/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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510(k) Number (if known):

Device Name: COPPER TONGUE SCRAPER

Indications For Use:

Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good It is intended for over-the-counter point of oral hygiene. sale as are other predicate devices.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rannes
(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)