The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Monobond Plus.
| Device ID | K090826 |
| 510k Number | K090826 |
| Device Name: | MONOBOND PLUS |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Donna M Hartnett |
| Correspondent | Donna M Hartnett IVOCLAR VIVADENT, 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 | 2009-03-26 |
| Decision Date | 2009-05-11 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() MONOBOND PLUS 85967559 4477829 Live/Registered |
Ivoclar Vivadent, Inc. 2013-06-24 |