The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Ionosit Seal.
| Device ID | K954867 |
| 510k Number | K954867 |
| Device Name: | IONOSIT SEAL |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | FOREMOST DENTAL MFG., INC. 242 SOUTH DEAN ST. Englewood, NJ 07631 |
| Contact | D. T. Wolf |
| Correspondent | D. T. 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 | 1995-10-24 |
| Decision Date | 1996-03-08 |
| Summary: | summary |