(11 days)
PerioSRP™ Tooth Root Conditioner with NovaMin® is a two-phase product intended for the rapid relief of hypersensitivity associated with exposed tooth root dentin. Studies have shown that PerioSRP™ Tooth Root Conditioner with NovaMin® is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
Not Found
I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain details about specific performance metrics, clinical study designs, or expert reviews as requested in your prompt.
The document discusses:
- The device name: PerioSRP™ Tooth Root Conditioner with NovaMin®
- Its intended use: rapid relief of hypersensitivity associated with exposed tooth root dentin, and its effectiveness at occluding exposed dentinal tubules.
- The FDA's determination of substantial equivalence and resulting market clearance.
Therefore, I cannot provide the requested table or answer the specific questions about sample size, expert qualifications, ground truth, or study methodologies.
§ 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.