K081287 is an FDA 510(k) clearance for the SAPPHIRE PLASMA ARC DENTAL CURING LIGHT. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Den-Mat Holdings, LLC (Santa Maria, US). The FDA issued a Cleared decision on November 21, 2008, 198 days after receiving the submission on May 7, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K081287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 07, 2008 |
| Decision Date | November 21, 2008 |
| Days to Decision | 198 days |
| Submission Type | Abbreviated |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBZ - Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |