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 |