The following data is part of a premarket notification filed by Degussa - Ney Dental, Inc. with the FDA for Cercon Ceram.
Device ID | K011333 |
510k Number | K011333 |
Device Name: | CERCON CERAM |
Classification | Powder, Porcelain |
Applicant | DEGUSSA - NEY DENTAL, INC. 65 WEST DUDLEY TOWN RD. Bloomfield, CT 06002 |
Contact | Thomas C Cameron |
Correspondent | Thomas C Cameron DEGUSSA - NEY DENTAL, INC. 65 WEST DUDLEY TOWN RD. Bloomfield, CT 06002 |
Product Code | EIH |
CFR Regulation Number | 872.6660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-05-02 |
Decision Date | 2001-08-20 |