The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Sealdent.
| Device ID | K944466 |
| 510k Number | K944466 |
| Device Name: | SEALDENT |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-07 |
| Decision Date | 1995-03-02 |