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 |