The following data is part of a premarket notification filed by Premier Dental Company Products with the FDA for Zeramic Adhesive Resin Cement.
| Device ID | K150601 |
| 510k Number | K150601 |
| Device Name: | Zeramic Adhesive Resin Cement |
| Classification | Cement, Dental |
| Applicant | Premier Dental Company Products 1710 Romano Drive Plymouth Meeting, PA 19462 |
| Contact | Vincent D'alessandro |
| Correspondent | Vincent D'alessandro Premier Dental Company Products 1710 Romano Drive 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 | 2015-03-10 |
| Decision Date | 2015-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00348783000610 | K150601 | 000 |
| 00348783000597 | K150601 | 000 |
| 00348783000580 | K150601 | 000 |
| 00348783000573 | K150601 | 000 |