The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Ceramic Primer.
| Device ID | K131212 |
| 510k Number | K131212 |
| Device Name: | PREMIER CERAMIC PRIMER |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Contact | Vincent D'alessandro |
| Correspondent | Vincent D'alessandro PREMIER DENTAL PRODUCTS CO. 1710 ROMANO DR. Plymouth Meeting, PA 19462 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-29 |
| Decision Date | 2013-08-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D6913001569 | K131212 | 000 |
| D6913001568 | K131212 | 000 |
| 00348783000849 | K131212 | 000 |
| 00348783000634 | K131212 | 000 |
| 00348783000627 | K131212 | 000 |