The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Silimat Plus.
| Device ID | K923974 |
| 510k Number | K923974 |
| Device Name: | SILIMAT PLUS |
| Classification | Amalgamator, Dental, Ac-powered |
| 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 | EFD |
| CFR Regulation Number | 872.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-07 |
| Decision Date | 1992-10-06 |