K012341 is an FDA 510(k) clearance for the TRANSLUX ENERGY. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Heraeus Kulzer, Inc. (South Bend, US). The FDA issued a Cleared decision on August 30, 2001, 37 days after receiving the submission on July 24, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K012341 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 24, 2001 |
| Decision Date | August 30, 2001 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| 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 |