The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Dental Casting Alloy Gdc 1686.
Device ID | K852347 |
510k Number | K852347 |
Device Name: | DENTAL CASTING ALLOY GDC 1686 |
Classification | Alloy, Other Noble Metal |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | Scott Brooks |
Correspondent | Scott Brooks DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Product Code | EJS |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-31 |
Decision Date | 1985-07-31 |