(55 days)
Use to remove surface tongue debris, residue, plaque or filmy build-up that result from eating, drinking, smoking or other types of consumption which can lead to bad breath. Also may be used to remove salivary tongue plaques and residue that naturally accumulate during sleep or between cleanings.
Not Found
This document is a 510(k) clearance letter from the FDA for a device called "Cybersonic" with K980075. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter simply states that the FDA has determined the device to be substantially equivalent to devices marketed prior to May 28, 1976.
Therefore, I cannot provide the requested information from this document.
§ 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.