The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Casting Alloy For Porcelain-fused-to-metal Restor..
Device ID | K892907 |
510k Number | K892907 |
Device Name: | CASTING ALLOY FOR PORCELAIN-FUSED-TO-METAL RESTOR. |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | John M Kuzmech |
Correspondent | John M Kuzmech DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-04-20 |
Decision Date | 1989-06-06 |