The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Foremost Dentin Adhesive.
Device ID | K864898 |
510k Number | K864898 |
Device Name: | FOREMOST DENTIN ADHESIVE |
Classification | Cement, Dental |
Applicant | FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
Contact | Wolf |
Correspondent | Wolf FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
Product Code | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-12-15 |
Decision Date | 1987-02-12 |