The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Curay Join Dent Dentin Primer.
| Device ID | K850675 |
| 510k Number | K850675 |
| Device Name: | CURAY JOIN DENT DENTIN PRIMER |
| Classification | Coating, Filling Material, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Contact | Jan Orlowski |
| Correspondent | Jan Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 1828 EVERGREEN ST. Duarte, CA 91010 |
| Product Code | EBD |
| CFR Regulation Number | 872.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-02-21 |
| Decision Date | 1985-03-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D801SP7008N1 | K850675 | 000 |
| D801ID5012I1 | K850675 | 000 |
| D801SP501201 | K850675 | 000 |
| D801SP50120S1 | K850675 | 000 |
| D801SP501211 | K850675 | 000 |
| D801SP50121N1 | K850675 | 000 |
| D801SP50122B1 | K850675 | 000 |
| D801SP50122N1 | K850675 | 000 |
| D801SP50125B1 | K850675 | 000 |
| D801SP50125BS1 | K850675 | 000 |
| D801SP7007B1 | K850675 | 000 |
| D801SP7007N1 | K850675 | 000 |
| D801SP7008B1 | K850675 | 000 |
| D801ID50121I1 | K850675 | 000 |