The following data is part of a premarket notification filed by Degussa - Ney Dental, Inc. with the FDA for Definite.
| Device ID | K993514 |
| 510k Number | K993514 |
| Device Name: | DEFINITE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | DEGUSSA - NEY DENTAL, INC. 65 WEST DUDLY TOWN RD. Bloomfield, CT 06002 |
| Contact | Thomas B Cameron |
| Correspondent | Thomas B Cameron DEGUSSA - NEY DENTAL, INC. 65 WEST DUDLY TOWN RD. Bloomfield, CT 06002 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-18 |
| Decision Date | 2000-02-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() DEFINITE 78625072 not registered Dead/Abandoned |
Maria Guadalupe Garza 2005-05-06 |
![]() DEFINITE 75527045 not registered Dead/Abandoned |
DEGUSSA AKTIENGESELLSCHAFT 1998-07-27 |
![]() DEFINITE 72170142 0766071 Dead/Cancelled |
Wyandotte Chemicals Corporation 1963-05-31 |