The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Provilink.
Device ID | K950060 |
510k Number | K950060 |
Device Name: | PROVILINK |
Classification | Cement, Dental |
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 | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-06 |
Decision Date | 1995-02-10 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PROVILINK 74679031 1979570 Dead/Cancelled |
IVOCLAR VIVADENT, INC. 1995-05-23 |