The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Harmony Line Pf.
| Device ID | K950517 |
| 510k Number | K950517 |
| Device Name: | HARMONY LINE PF |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
| Contact | Looyd V Ziemendorf |
| Correspondent | Looyd V 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 | 1995-02-06 |
| Decision Date | 1995-03-23 |