K080549 is an FDA 510(k) clearance for the DURAFINISH ALL-CURE, MODEL S296. This device is classified as a Coating, Filling Material, Resin (Class II - Special Controls, product code EBD).
Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on May 13, 2008, 76 days after receiving the submission on February 27, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3310.
| 510(k) Number | K080549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 2008 |
| Decision Date | May 13, 2008 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBD — Coating, Filling Material, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3310 |