The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Vivaglass Liner.
Device ID | K931502 |
510k Number | K931502 |
Device Name: | VIVAGLASS LINER |
Classification | Liner, Cavity, Calcium Hydroxide |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Lloyd Ziemendorf |
Correspondent | Lloyd Ziemendorf IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EJK |
CFR Regulation Number | 872.3250 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-03-25 |
Decision Date | 1993-07-22 |