The following data is part of a premarket notification filed by Kulzer, Inc. with the FDA for Dentacolor Light Curing Crown & Bridge.
| Device ID | K831215 |
| 510k Number | K831215 |
| Device Name: | DENTACOLOR LIGHT CURING CROWN & BRIDGE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | KULZER, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-14 |
| Decision Date | 1983-09-12 |