The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Coltolux Led Curing Light.
| Device ID | K040551 |
| 510k Number | K040551 |
| Device Name: | COLTOLUX LED CURING LIGHT |
| Classification | Activator, Ultraviolet, For Polymerization |
| Applicant | COLTENE/WHALEDENT INC. 1349 LEXINGTON AVE. New York, NY 10128 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE/WHALEDENT INC. 1349 LEXINGTON AVE. New York, NY 10128 |
| Product Code | EBZ |
| CFR Regulation Number | 872.6070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-02 |
| Decision Date | 2004-03-15 |