The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Coltolux 3, Coltolux 4.
| Device ID | K945698 |
| 510k Number | K945698 |
| Device Name: | COLTOLUX 3, COLTOLUX 4 |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Contact | H J Vogelstein |
| Correspondent | H J Vogelstein COLTENE/WHALEDENT INC. 750 CORPORATE DR. Mahwah, NJ 07430 -2009 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-17 |
| Decision Date | 1995-05-24 |