The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Compcore Af Composite Core Build-up Material, Model 3001408.
| Device ID | K012160 |
| 510k Number | K012160 |
| Device Name: | COMPCORE AF COMPOSITE CORE BUILD-UP MATERIAL, MODEL 3001408 |
| Classification | Material, Tooth Shade, Resin |
| Applicant | PREMIER DENTAL PRODUCTS CO. 7707 E. 201 TERR Belton, MO 64012 |
| Contact | Barry Hale |
| Correspondent | Barry Hale PREMIER DENTAL PRODUCTS CO. 7707 E. 201 TERR Belton, MO 64012 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-11 |
| Decision Date | 2001-09-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10304040006228 | K012160 | 000 |
| 00348783000726 | K012160 | 000 |
| 00348783000733 | K012160 | 000 |
| 00348783000740 | K012160 | 000 |
| 00348783000764 | K012160 | 000 |
| 00348783000771 | K012160 | 000 |
| 00348783000788 | K012160 | 000 |
| 00348783000795 | K012160 | 000 |
| 00348783000801 | K012160 | 000 |
| 10304040006211 | K012160 | 000 |
| 00348783000719 | K012160 | 000 |