(74 days)
Enamel Pro® Varnish is a fluoride containing preparation for the treatment of dentinal hypersensitivity, and for the reduction of post operative sensitivity. The varnish can be placed on sensitive root surfaces and under temporary restoratives and cements in order to seal exposed dentinal tissue. It can be used as a cavity liner.
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I am sorry but this document does not contain the information you are looking for. The document is an FDA clearance letter for a dental varnish (Enamel Pro® Varnish) and focuses on its substantial equivalence to a legally marketed predicate device, rather than detailed acceptance criteria and a study proving device performance as typically expected for imaging or AI-driven medical devices.
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§ 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.