The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Curay-support, Core Build-up Material.
| Device ID | K832781 |
| 510k Number | K832781 |
| Device Name: | CURAY-SUPPORT, CORE BUILD-UP MATERIAL |
| Classification | Material, Tooth Shade, Resin |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-16 |
| Decision Date | 1983-10-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526022095 | K832781 | 000 |
| D6864141839 | K832781 | 000 |
| 00816526021098 | K832781 | 000 |
| 00816526021104 | K832781 | 000 |
| 00816526021111 | K832781 | 000 |
| 00816526021128 | K832781 | 000 |
| 00816526021135 | K832781 | 000 |
| 00816526021142 | K832781 | 000 |
| 00816526021159 | K832781 | 000 |
| 00816526022088 | K832781 | 000 |
| D686414183 | K832781 | 000 |