The following data is part of a premarket notification filed by Dentaurum, Inc. with the FDA for Triceram.
| Device ID | K011428 |
| 510k Number | K011428 |
| Device Name: | TRICERAM |
| Classification | Powder, Porcelain |
| Applicant | DENTAURUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | Thomas J Anderson |
| Correspondent | Thomas J Anderson DENTAURUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | EIH |
| CFR Regulation Number | 872.6660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-09 |
| Decision Date | 2001-06-05 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TRICERAM 76197914 2722092 Dead/Cancelled |
CERAGENIX PHARMACEUTICALS, INC. AND CERAGENIX CORPORATION 2001-01-22 |