TONGUE KLEAN

K973175 · Softek Ent. · LCN · Oct 14, 1997 · Dental

Device Facts

• Record ID: K973175
• Device Name: TONGUE KLEAN
• Applicant: Softek Ent.
• Product Code: LCN · Dental
• Decision Date: Oct 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6855
• Device Class: Class 1

Intended Use

TONGUE KLEAN IS INDICATED FOR THE ORAL HYGIENE DAILY TO REMOVE PLAQUE FROM THE SURFACE OF THE TONGUE.

Device Story

Tongue Klean is a manual tongue scraper used for daily oral hygiene. The device functions by mechanically scraping plaque buildup from the surface of the tongue. It is intended for over-the-counter use by individuals to maintain oral cleanliness. The device is a simple, non-powered tool.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual tongue scraper; simple mechanical design; non-powered.

Indications for Use

Indicated for daily oral hygiene to remove plaque from the surface of the tongue for general users.

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

• OOLITT (K962941)

Submission Summary (Full Text)

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K973175

OCT 1 4 1997

## SUMMARY OF 510(k)

TRADE NAME: Tongue Klean CLASSIFICATION NAME: Tongue Scraper COMMON NAME: Tongue Scraper

OOLITT, D.T. Corp., Premarket Notification K 962941 Predicate Device:

## Device Description

Softek's Tongue Klean is a simple device which is used to scrape build up of plaque from the surface of the tongue. Tongue Klean is easy to use and does not present any undue risk to the user of Tongue Klean.

## Substantial Equivalency:

Softek Tongue Klean is similar in design and has the same Technological characteristics as "OOLITT" and has same indications for use.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

Mr. Promila Gupta Softek Enterprises 5245 S. Hanover Way Englewood, Colorado 80111

OCT 1 4 1997

Re : K973175 Tongue Klean Trade Name: Regulatory Class: Unclassified Product Code: LCN Dated: August 18, 1997 Received: Auqust 25, 1997

Dear Mr. Gupta:

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, qood 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. ਸ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory 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. Gupta

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 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

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

. Enclosure

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| 510(k) Number (if known): | |
|---------------------------|--------------|
| Device Name: | TONGUE KLEAN |
| Indications For Use: | |

TONGUE KILEAN ાં ટ INDICATED for ೧೭೯ નિર્ડ PART THE ORAL HYSIENE DALLY TO OF FROM THE SURFACE PLAQUE REMOVE TONGUE Of THE

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rummer

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

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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