(44 days)
- treatment of hypersensitive dentine
- treatment of cervical areas (including crown margins, after tooth cleaning or tartar removal, exposed cervical areas etc.)
Not Found
The provided text is an FDA 510(k) clearance letter for a dental device, "Admira Protect." It does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria as typically understood for medical device performance evaluation using AI.
The letter simply states that the FDA has reviewed the 510(k) premarket notification and determined the device is "substantially equivalent" to legally marketed predicate devices. This indicates a regulatory clearance process rather than a performance study with defined acceptance criteria and results.
Therefore, I cannot extract the requested information from the provided document. The document primarily focuses on regulatory approval based on substantial equivalence, and not on detailed performance study results against specific acceptance criteria.
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(b)
Classification. Class II.