The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Enamel Pro Varnish.
| Device ID | K062683 |
| 510k Number | K062683 |
| Device Name: | ENAMEL PRO VARNISH |
| Classification | Varnish, Cavity |
| 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 | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2006-09-08 |
| Decision Date | 2006-11-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00348783005677 | K062683 | 000 |
| 10348783005667 | K062683 | 000 |
| 10348783005650 | K062683 | 000 |
| 10348783005643 | K062683 | 000 |
| 10348783005636 | K062683 | 000 |
| 10348783005629 | K062683 | 000 |
| 10348783005612 | K062683 | 000 |
| 10348783005605 | K062683 | 000 |
| 10348783005599 | K062683 | 000 |