The following data is part of a premarket notification filed by Heraeus Kulzer, Inc. with the FDA for Dentacolor(r) Cre-active.
| Device ID | K914456 |
| 510k Number | K914456 |
| Device Name: | DENTACOLOR(R) CRE-ACTIVE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Contact | Sharon Parker |
| Correspondent | Sharon Parker HERAEUS KULZER, INC. 10005 MUIRLANDS BLVD. Irvine, CA 92718 -2595 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1992-03-11 |