OOLI-U(TONGUE SCRAPER)
Device Facts
| Record ID | K970042 |
|---|---|
| Device Name | OOLI-U(TONGUE SCRAPER) |
| Applicant | Telefax Intl. |
| Product Code | LCN · Dental |
| Decision Date | Mar 14, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6855 |
| Device Class | Class 1 |
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.
Indications for Use
Indicated for individuals seeking to remove plaque and food debris from the tongue surface.
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)
Related Devices
- K973424 — ENFRESH TONGUE BRUSH · Enfresh Products, LLC · Dec 9, 1997
- K990344 — ORALGIENE TONGUE CLEANER · Oralgiene USA, Inc. · May 4, 1999
- K983087 — BREATHTIQUE TONGUE SCRAPER · Custom Medical Arts, Inc. · Nov 18, 1998
- K983683 — UNIK TONGUE CLEANER · Unik Products, Inc. · Jan 14, 1999
- K973175 — TONGUE KLEAN · Softek Ent. · Oct 14, 1997
Submission Summary (Full Text)
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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
