← Product Code [LCN](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/LCN) · K970042

# OOLI-U(TONGUE SCRAPER) (K970042)

_Telefax Intl. · LCN · Mar 14, 1997 · Dental · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/LCN/K970042

## Device Facts

- **Applicant:** Telefax Intl.
- **Product Code:** [LCN](/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/LCN.md)
- **Decision Date:** Mar 14, 1997
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 872.6855
- **Device Class:** Class 1
- **Review Panel:** Dental

## Indications for Use

The device is intended to remove plaque and food debris from the surface of the tongue.

## Device Story

Manual tongue scraper; formed stainless steel piece; used to remove plaque and food debris from tongue surface; operated by patient; simple mechanical action; no electronic or software components.

## Clinical Evidence

No clinical data; bench testing only.

## Technological Characteristics

Formed stainless steel; manual operation; no energy source; no software; no connectivity.

## Regulatory 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](/device/K961574.md))

## Submission Summary (Full Text)

> This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com.
>
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Telefax International
23704-5 El Toro Road,
Suite # 527
Lake Forest, CA 92630.
MAR 14 1997
K970042

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR Part 807.92.

# SUMMARY OF SAFETY AND EFFECTIVENESS FOR OOLI-U (TONGUE SCRAPER)

Monday, December 30, 1996

1. Telefax International, 23704-5 El Toro Road, Ste. 527, Lake Forest, CA 92630.
Contact Person: Upen Shah, Tel.: (714)-581-1447, Fax: (714)-581-1448.

2. Proprietary Name: Ooli-U
Common/Usual Name: Tongue Scraper/Tongue Cleaner
Classification Name: Tongue Scraper

3. Predicate Device: U.S. Dentek' Sakool (K961574).

4. Description of Device: The device is a formed piece of stainless steel.

5. Intended Use: The device is intended to remove plaque and food debris from the surface of the tongue.

6. Technological Characteristics: The only known difference from the predicate device, is the material from which is made of. Ours is stainless steel material that is commonly used in dental equipment and theirs is a plastic. From using these devices, the results are the same.

7. Summary of Performance Data: Not Applicable.

8. Conclusions Drawn From Nonclinical and Clinical Tests: Not Applicable..

Phone: (714)-581-1447
Fax: (714)-581-1448

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/LCN/K970042](https://fda.innolitics.com/submissions/DE/subpart-g%E2%80%94miscellaneous-devices/LCN/K970042)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com