(177 days)
For use as a varnish on sensitive teeth over exposed dentin and under temporary restoratives and cements.
The varnish has the consistency of a viscous liquid. When applied in a thin layer over tooth dentin, the solvent (ethyl alcohol and water) evaporates within a few minutes, leaving a film of Colophony resin in which Sodium Fluoride is suspended, which adheres well to the tooth structure.
This document focuses on the substantial equivalence of the Sci-Pharm DFV Varnish to legally marketed predicate devices, rather than establishing acceptance criteria or performance through a clinical study with numerical metrics like sensitivity, specificity, or accuracy.
The manufacturer, Scientific Pharmaceuticals, Inc., sought 510(k) clearance from the FDA for their Sci-Pharm DFV Varnish. The clearance relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, not on meeting specific, pre-defined acceptance criteria through a clinical performance study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This type of table is not directly applicable here because the submission is based on substantial equivalence, not a performance study against specific acceptance criteria. Instead, the document compares the chemical composition and device function to predicate devices.
| Feature / Criterion | Predicate Device (Duraphat/Durafluor) | Sci-Pharm DFV Varnish Performance |
|---|---|---|
| Material/Composition | ||
| Ethyl Alcohol | 75% | 71.25% |
| Colophony | 20% | 20% |
| Sodium Fluoride | 5% | 5% |
| Water |
§ 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.