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 |