The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Dw243-64.
| Device ID | K923644 |
| 510k Number | K923644 |
| Device Name: | DW243-64 |
| Classification | Alloy, Other Noble Metal |
| Applicant | IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
| Contact | Lloyd V Ziemendorf |
| Correspondent | Lloyd V Ziemendorf IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-21 |
| Decision Date | 1992-11-04 |