The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Foremost Dentin Adhesive.
Device ID | K845033 |
510k Number | K845033 |
Device Name: | FOREMOST DENTIN ADHESIVE |
Classification | Material, Tooth Shade, Resin |
Applicant | FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
Contact | Tim Wolf |
Correspondent | Tim Wolf FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-27 |
Decision Date | 1985-03-18 |