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 |