(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.
§ 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.