The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Prime & Bond Nt Dual Cure Universal Dental Adhesive System.
| Device ID | K982394 |
| 510k Number | K982394 |
| Device Name: | PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P.jeffery Lehn |
| Correspondent | P.jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-09 |
| Decision Date | 1998-09-21 |
| Summary: | summary |