The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Twin-core.
| Device ID | K863031 |
| 510k Number | K863031 |
| Device Name: | TWIN-CORE |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-11 |
| Decision Date | 1986-09-22 |