(102 days)
Protect™ Tooth Desensitizer is a film-like varnish indicated for the treatment of tooth sensitivities.
Protect™ Tooth Desensitizer is a film-like varnish.
I am sorry, but the provided text does not contain the information needed to describe the acceptance criteria and the study that proves the device meets those criteria. The documents are related to an FDA 510(k) submission for a tooth desensitizer, but they don't include details about a performance study, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment. They primarily focus on regulatory aspects like classification, predicate devices, and intended use.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.