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 |