K051750 is an FDA 510(k) clearance for the FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 19, 2005, 82 days after receiving the submission on June 29, 2005.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K051750 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2005 |
| Decision Date | September 19, 2005 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | LBH — Varnish, Cavity |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3260 |