The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Dental Casting Alloy, Modification - Pf-3.
Device ID | K930482 |
510k Number | K930482 |
Device Name: | DENTAL CASTING ALLOY, MODIFICATION - PF-3 |
Classification | Alloy, Gold-based Noble Metal |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | R Trierweiler |
Correspondent | R Trierweiler 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 | 1993-01-29 |
Decision Date | 1993-03-31 |