The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Gdc 1742 (a Casting Alloy For Dental Restorations).
Device ID | K860119 |
510k Number | K860119 |
Device Name: | GDC 1742 (A CASTING ALLOY FOR DENTAL RESTORATIONS) |
Classification | Alloy, Other Noble Metal |
Applicant | DERINGER-NEY INC. NEY INDUSTRIAL PARK Bloomfield, CT 06002 |
Contact | Donald V Landmann |
Correspondent | Donald V Landmann 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 | 1986-01-13 |
Decision Date | 1986-03-17 |