K992629 is an FDA 510(k) clearance for the D/SENSE II (GREEN-OR) DENTIN DESENSITIZER. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on October 22, 1999, 86 days after receiving the submission on July 28, 1999.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K992629 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1999 |
| Decision Date | October 22, 1999 |
| Days to Decision | 86 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |