(63 days)
The Ayurvedic Tongue Cleaner is a device used to remove food particles and debris from the tongue. It is used to complement an overall oral hygiene program that includes brushing and flossing the teeth and gums. It is not a substitute for any other oral hygiene care such as brushing and flossing the teeth and gums.
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The provided text is a 510(k) premarket notification letter from the FDA regarding an "Ayurvedic Tongue Cleaner." This document primarily addresses the substantial equivalence determination of the device to legally marketed predicate devices, allowing its market entry. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment—all of which are typical components of a technical study report for a medical device.
Therefore, I cannot fulfill your request for this information based on the provided text. The document is regulatory approval, not a performance study.
§ 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.