The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Monobond Etch & Prime.
| Device ID | K150164 |
| 510k Number | K150164 |
| Device Name: | Monobond Etch & Prime |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | IVOCLAR VIVADENT AG BENDERERSTRASSE 2 Schaan, LI Fl-9494 |
| Contact | Sandra Cakebread |
| Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DRIVE 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 | 2015-01-26 |
| Decision Date | 2015-04-03 |
| Summary: | summary |