The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Harmony Line Alloys.
Device ID | K905330 |
510k Number | K905330 |
Device Name: | HARMONY LINE ALLOYS |
Classification | Alloy, Gold-based Noble Metal |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | Gary L Severance |
Correspondent | Gary L Severance 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 | 1990-11-28 |
Decision Date | 1990-12-24 |