The following data is part of a premarket notification filed by Ivoclar Vivadent Ag with the FDA for Adhese Universal.
Device ID | K133318 |
510k Number | K133318 |
Device Name: | ADHESE UNIVERSAL |
Classification | Agent, Tooth Bonding, Resin |
Applicant | IVOCLAR VIVADENT AG 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Donna Hartnett |
Correspondent | Donna Hartnett IVOCLAR VIVADENT AG 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 | 2013-10-28 |
Decision Date | 2014-02-11 |
Summary: | summary |