(11 days)
Intended for use as a varnish on sensitive teeth over exposed dentin under temporary restoratives and cements where post-operative sensitivity is a concern and to improve quality and functionality of restorations when used in conjunction with dental restoratives and cements. To seal dentinal tubules in cavity preparations or on sensitive root surfaces.
The modified varnish has the following similarities to that which previously received 510(k) concurrence:
- Has the same active ingredient at the same concentration; .
- has the same indications for use; .
- incorporate the same or similar materials; .
- has the same shelf life, and; ●
- is packaged using the same materials and processes.
I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details, or ground truth establishment. The document is primarily a 510(k) summary and an FDA clearance letter for a dental varnish, outlining its substantial equivalence to a predicate device and its indications for use. It does not include the results of a clinical study or performance testing.
§ 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.