The following data is part of a premarket notification filed by Degussa - Ney Dental, Inc. with the FDA for Cergogold.
| Device ID | K993897 |
| 510k Number | K993897 |
| Device Name: | CERGOGOLD |
| Classification | Powder, Porcelain |
| Applicant | DEGUSSA - NEY DENTAL, INC. 1065 S.W. 30TH AVE. Deerfield Beach, FL 33442 -8193 |
| Contact | Andrew J Pietrobono |
| Correspondent | Andrew J Pietrobono DEGUSSA - NEY DENTAL, INC. 1065 S.W. 30TH AVE. Deerfield Beach, FL 33442 -8193 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-16 |
| Decision Date | 2000-01-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CERGOGOLD 75704879 2526498 Dead/Cancelled |
DEGUDENT GMBH 1999-05-14 |