The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Syntac (dentin Bonding Agent).
| Device ID | K901913 |
| 510k Number | K901913 |
| Device Name: | SYNTAC (DENTIN BONDING AGENT) |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | L Severance,dds |
| Correspondent | L Severance,dds IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-26 |
| Decision Date | 1990-06-26 |