The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Ez Gold.
Device ID | K915626 |
510k Number | K915626 |
Device Name: | EZ GOLD |
Classification | Alloy, Gold-based Noble Metal |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Lloyd Ziemendorf |
Correspondent | Lloyd Ziemendorf IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EJT |
CFR Regulation Number | 872.3060 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-17 |
Decision Date | 1992-02-25 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
EZ GOLD 73587260 1419761 Dead/Cancelled |
PRECISION TWIST DRILL CO. 1986-03-10 |