(77 days)
Copper Tongue Scraper's intend use is to remove bacteria and food debris from the tongue surface, hence promoting good oral hygiene. It is intended for over-the-counter point of sale as are other predicate devices.
This device is a U-formed design made of Copper.
The provided text does not contain any information about acceptance criteria or a study demonstrating that the device meets such criteria.
The document is a 510(k) summary for the Copper Tongue Scraper, which focuses on establishing substantial equivalence to predicate devices rather than presenting performance metrics against specific acceptance criteria.
Therefore, I cannot populate the requested table or answer the questions based on the provided input.
§ 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.