DURAGARD SODIUM FLUORIDE VARNISH
Device Facts
| Record ID | K002581 |
|---|---|
| Device Name | DURAGARD SODIUM FLUORIDE VARNISH |
| Applicant | Sultan Dental Products, Ltd. |
| Product Code | LBH · Dental |
| Decision Date | Oct 20, 2000 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3260 |
| Device Class | Class 2 |
Regulatory Classification
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.
Special Controls
*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.
