The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Kulzer Translux Visible Light Curing.
| Device ID | K811668 |
| 510k Number | K811668 |
| Device Name: | KULZER TRANSLUX VISIBLE LIGHT CURING |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | KULZER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-15 |
| Decision Date | 1981-07-28 |