The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for Type 1 Dental Cement.
Device ID | K921173 |
510k Number | K921173 |
Device Name: | TYPE 1 DENTAL CEMENT |
Classification | Cement, Dental |
Applicant | CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
Contact | John Discko |
Correspondent | John Discko CENTRIX, INC. 30 STRAN RD. Milford, CT 06460 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-03-11 |
Decision Date | 1992-11-04 |