The following data is part of a premarket notification filed by Deringer-ney Inc. with the FDA for Ultima Lite.
Device ID | K890568 |
510k Number | K890568 |
Device Name: | ULTIMA LITE |
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 | 1989-02-06 |
Decision Date | 1989-03-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ULTIMA LITE 78234652 2819981 Live/Registered |
DENTSPLY SIRONA INC. 2003-04-07 |
ULTIMA LITE 73821808 1591667 Dead/Cancelled |
J. M. NEY COMPANY, THE 1989-08-28 |