The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Dw242-07 Non-precious Alloy F/ Porcelain Fus. Met..
| Device ID | K920561 |
| 510k Number | K920561 |
| Device Name: | DW242-07 NON-PRECIOUS ALLOY F/ PORCELAIN FUS. MET. |
| Classification | Alloy, Metal, Base |
| 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 | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-02-06 |
| Decision Date | 1992-03-02 |