VARIOLINK
Material, Tooth Shade, Resin
IVOCLAR NORTH AMERICA, INC.
The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Variolink.
Pre-market Notification Details
| Device ID | K931309 |
| 510k Number | K931309 |
| Device Name: | VARIOLINK |
| 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 | 1993-03-15 |
| Decision Date | 1993-07-22 |
Trademark Results [VARIOLINK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VARIOLINK 79054012 3635508 Dead/Cancelled |
Océ-Technologies B.V. 2008-05-05 |
 VARIOLINK 74679076 1965731 Live/Registered |
IVOCLAR VIVADENT, INC. 1995-05-23 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.