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 |