The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Zenith 40% Phosphoric Acid Gel.
| Device ID | K890464 |
| 510k Number | K890464 |
| Device Name: | ZENITH 40% PHOSPHORIC ACID GEL |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-30 |
| Decision Date | 1989-02-13 |