(90 days)
VOCO Profluorid L is intended for use as
- treatment of hypersensitive teeth,
- sealing the dentinal tubules for cavity preparations or on sensitive root surfaces cavity liner under amalgam restorations
Not Found
This document is a 510(k) premarket notification decision letter from the FDA for a dental product called "VOCO Profluorid L". It primarily focuses on regulatory approval and does not contain details about acceptance criteria, study designs, or performance metrics for a device in the way a clinical study report or a technical performance document would.
Therefore, I cannot extract the requested information about acceptance criteria and study details from the provided text. The document confirms that the device is "substantially equivalent" to legally marketed predicate devices, which is the basis for its market approval. However, it does not provide the specific performance data or study methodology that would typically be contained within a device's submission to demonstrate that equivalence.
§ 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.