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 |