(67 days)
The device is intended to remove plaque and food debris from the surface of the tongue.
The device is a formed piece of stainless steel.
The provided text describes a 510(k) summary for a tongue scraper, focusing on its safety, effectiveness, and comparison to a predicate device. However, it does not contain any information about acceptance criteria or a study proving that a device meets those criteria.
The document states:
- "Summary of Performance Data: Not Applicable."
- "Conclusions Drawn From Nonclinical and Clinical Tests: Not Applicable."
This clearly indicates that no performance studies, clinical or non-clinical, were conducted or are being reported in this submission for this specific device. The submission relies solely on the substantial equivalence to a predicate device (U.S. Dentek' Sakool, K961574) and the fact that the only known difference is the material (stainless steel vs. plastic), with the claim that "From using these devices, the results are the same."
Therefore, I cannot provide the requested information, as it is not present in the input text.
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Image /page/0/Picture/0 description: The image shows a black and white illustration of a geometric structure. The structure appears to be made of a grid-like pattern, with curved shapes that resemble arches or domes. The image has a high contrast, with the black lines of the grid standing out against the white background. The overall impression is one of a complex, abstract design.
Telefax International 23704-5 El Toro Road, Suite # 527 Lake Forest, CA 92630.
MAR 1 4 1997
970042
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
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- 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. న : 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 ..
§ 872.6855 Manual toothbrush.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.