The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Dw 215-12a Alloy For Forcelain Fused To Metal.
| Device ID | K920613 |
| 510k Number | K920613 |
| Device Name: | DW 215-12A ALLOY FOR FORCELAIN FUSED TO METAL |
| Classification | Alloy, Other Noble Metal |
| 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 | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-11 |
| Decision Date | 1992-04-21 |