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 |