The following data is part of a premarket notification filed by Foremost Dental Mfg., Co. with the FDA for Ionosit Base Liner.
| Device ID | K935689 |
| 510k Number | K935689 |
| Device Name: | IONOSIT BASE LINER |
| Classification | Coating, Filling Material, Resin |
| Applicant | FOREMOST DENTAL MFG., CO. 242 S. DEAN ST. Englewood, NJ 07631 |
| Contact | D.t. Wolf |
| Correspondent | D.t. Wolf FOREMOST DENTAL MFG., CO. 242 S. DEAN ST. Englewood, NJ 07631 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-29 |
| Decision Date | 1994-01-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| EDMG22911 | K935689 | 000 |
| EDMG2230021 | K935689 | 000 |
| EDMG2109111 | K935689 | 000 |