The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Vivalux.
Device ID | K926556 |
510k Number | K926556 |
Device Name: | VIVALUX |
Classification | Material, Tooth Shade, Resin |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Lloyd V Ziemendorf |
Correspondent | Lloyd V Ziemendorf IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-12-31 |
Decision Date | 1993-04-23 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() VIVALUX 98094973 not registered Live/Pending |
Shenzhen Yirenshang Business Co., Ltd. 2023-07-20 |
![]() VIVALUX 74186061 1802589 Dead/Cancelled |
Etablissement Vivadent 1991-07-18 |