The following data is part of a premarket notification filed by Unitek Corp. with the FDA for Ortholux Visible Light Curing Unit.
| Device ID | K880392 |
| 510k Number | K880392 |
| Device Name: | ORTHOLUX VISIBLE LIGHT CURING UNIT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Contact | Marlyn Scheff |
| Correspondent | Marlyn Scheff UNITEK CORP. 2724 SOUTH PECK RD. Monrovia, CA 91016 -5097 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-29 |
| Decision Date | 1988-04-07 |