The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Premier Self-etching Enamel Sealant.
| Device ID | K061997 |
| 510k Number | K061997 |
| Device Name: | PREMIER SELF-ETCHING ENAMEL SEALANT |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-14 |
| Decision Date | 2006-10-04 |