ENAMEL PRO
Agent, Polishing, Abrasive, Oral Cavity
PREMIER DENTAL PRODUCTS CO.
The following data is part of a premarket notification filed by Premier Dental Products Co. with the FDA for Enamel Pro.
Pre-market Notification Details
| Device ID | K062166 |
| 510k Number | K062166 |
| Device Name: | ENAMEL PRO |
| Classification | Agent, Polishing, Abrasive, Oral 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 | EJR |
| CFR Regulation Number | 872.6030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-28 |
| Decision Date | 2006-11-21 |
Trademark Results [ENAMEL PRO]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENAMEL PRO 78446140 3118123 Live/Registered |
Premier Dental Products Company 2004-07-06 |
 ENAMEL PRO 77019889 3382472 Dead/Cancelled |
Premier Dental Products Company 2006-10-12 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.