K880392 is an FDA 510(k) clearance for the ORTHOLUX VISIBLE LIGHT CURING UNIT. This device is classified as a Activator, Ultraviolet, For Polymerization (Class II - Special Controls, product code EBZ).
Submitted by Unitek Corp. (Monrovia, US). The FDA issued a Cleared decision on April 7, 1988, 69 days after receiving the submission on January 29, 1988.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6070.
| 510(k) Number | K880392 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 1988 |
| Decision Date | April 07, 1988 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EBZ — Activator, Ultraviolet, For Polymerization |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.6070 |