The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Implant Cement, Model 3001450.
| Device ID | K033309 |
| 510k Number | K033309 |
| Device Name: | PREMIER IMPLANT CEMENT, MODEL 3001450 |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-14 |
| Decision Date | 2004-01-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6913001559 | K033309 | 000 |
| 00348783000146 | K033309 | 000 |
| 00348783000153 | K033309 | 000 |
| 00348783000160 | K033309 | 000 |
| 00348783000177 | K033309 | 000 |
| 00348783000184 | K033309 | 000 |
| 00348783000191 | K033309 | 000 |
| 00348783000566 | K033309 | 000 |
| D6913001551 | K033309 | 000 |
| D6913001555 | K033309 | 000 |
| D6913001556 | K033309 | 000 |
| 00348783000139 | K033309 | 000 |