The following data is part of a premarket notification filed by Premier Dental Company Products with the FDA for Premier Sealant.
| Device ID | K161580 |
| 510k Number | K161580 |
| Device Name: | Premier Sealant |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-08 |
| Decision Date | 2016-10-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00348783000887 | K161580 | 000 |
| 00348783000870 | K161580 | 000 |
| 00348783000863 | K161580 | 000 |
| 00348783000856 | K161580 | 000 |