(79 days)
To remove plaque and food debris from the surface of the tongue and to help fight bad breath and promote oral hygiene.
The device is a natural polypropylene band. It is formed into a u-shape by holding each end with the finger tips. The device is then placed on the back of the tongue and pulled forward gently with either the flat or rippled edge down. There are no sharp edges on the device.
The provided document is a 510(k) summary for the "MiracleBreath Tongue Cleaner," a manual tongue scraper.
This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.
The 510(k) summary focuses on the device description, contact information, and its substantial equivalence to predicate devices (other tongue cleaners) for its intended use (removing plaque and food debris from the tongue to help fight bad breath and promote oral hygiene).
Therefore, I cannot provide the requested information regarding acceptance criteria and a study to prove they are met because this information is not present in the provided 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.