The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Sr-ivocap Plus.
| Device ID | K915377 |
| 510k Number | K915377 |
| Device Name: | SR-IVOCAP PLUS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-29 |
| Decision Date | 1992-01-31 |