The following data is part of a premarket notification filed by Ivoclar Usa, Inc. with the FDA for Ariston Phc.
| Device ID | K981264 |
| 510k Number | K981264 |
| Device Name: | ARISTON PHC |
| Classification | Material, Tooth Shade, Resin |
| Applicant | IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
| Contact | Peter P Mancuso |
| Correspondent | Peter P Mancuso IVOCLAR USA, INC. 175 PINEVIEW DR. Amherst, NY 14150 |
| Product Code | EBF |
| CFR Regulation Number | 872.3690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-07 |
| Decision Date | 1998-07-02 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() ARISTON PHC 75503719 not registered Dead/Abandoned |
Ivoclar North America, Inc. 1998-06-18 |