The following data is part of a premarket notification filed by Dentsply International with the FDA for Prime & Bond Nt Dual Cure Nano-technology Universal Dental Adhesive System.
| Device ID | K050386 |
| 510k Number | K050386 |
| Device Name: | PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-15 |
| Decision Date | 2005-02-23 |