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 |