The following data is part of a premarket notification filed by Ortho Source with the FDA for Fissure Sealer.
| Device ID | K913853 |
| 510k Number | K913853 |
| Device Name: | FISSURE SEALER |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Contact | Andrea G Mustachio |
| Correspondent | Andrea G Mustachio ORTHO SOURCE 12021 RIVERSIDE DR. SUITE 201 North Hollywood, CA 91607 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-27 |
| Decision Date | 1992-08-27 |