The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Prime & Bond 2.1 M.p. Dentin/enamel Bonding Agent W/activator.
| Device ID | K964525 |
| 510k Number | K964525 |
| Device Name: | PRIME & BOND 2.1 M.P. DENTIN/ENAMEL BONDING AGENT W/ACTIVATOR |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | DENTSPLY INTL. 500 WEST COLLEGE AVE. York, PA 17405 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 500 WEST COLLEGE AVE. York, PA 17405 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-12 |
| Decision Date | 1997-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0026344020 | K964525 | 000 |
| D6870099405FG2 | K964525 | 000 |