The following data is part of a premarket notification filed by Ivoclar Vivadent, Inc. with the FDA for Vivasens.
Device ID | K030922 |
510k Number | K030922 |
Device Name: | VIVASENS |
Classification | Varnish, Cavity |
Applicant | IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Donna Marie Hartnett |
Correspondent | Donna Marie Hartnett IVOCLAR VIVADENT, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-03-24 |
Decision Date | 2003-10-17 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIVASENS 76582053 not registered Dead/Abandoned |
Ivoclar Vivadent, Inc. 2003-10-16 |