K100540 is an FDA 510(k) clearance for the ASCENT F-COAT MODEL: 006-00097. This device is classified as a Varnish, Cavity (Class II - Special Controls, product code LBH).
Submitted by CAO Group, Inc. (West Jordan, US). The FDA issued a Cleared decision on September 23, 2010, 210 days after receiving the submission on February 25, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3260.
| 510(k) Number | K100540 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 2010 |
| Decision Date | September 23, 2010 |
| Days to Decision | 210 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 |