K042199 is an FDA 510(k) clearance for the TRANSLUX POWER BLUE. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Heraeus Kulzer,GmbH (South Bend, US). The FDA issued a Cleared decision on September 8, 2004, 26 days after receiving the submission on August 13, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K042199 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 13, 2004 |
| Decision Date | September 08, 2004 |
| Days to Decision | 26 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBZ — Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |