The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Temporary Cement.
| Device ID | K051866 |
| 510k Number | K051866 |
| Device Name: | PREMIER TEMPORARY CEMENT |
| Classification | Cement, Dental |
| Applicant | PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Contact | Vince D'alessandro |
| Correspondent | Vince D'alessandro PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-11 |
| Decision Date | 2005-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6913001470 | K051866 | 000 |
| 00348783000214 | K051866 | 000 |
| 00348783000207 | K051866 | 000 |