The following data is part of a premarket notification filed by Ivoclar North America, Inc. with the FDA for Dual Cement.
Device ID | K901917 |
510k Number | K901917 |
Device Name: | DUAL CEMENT |
Classification | Material, Tooth Shade, Resin |
Applicant | IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Contact | L Severance,dds |
Correspondent | L Severance,dds IVOCLAR NORTH AMERICA, INC. 175 PINEVIEW DR. Amherst, NY 14228 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-26 |
Decision Date | 1990-06-28 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
DUAL CEMENT 75101486 2111749 Live/Registered |
IVOCLAR VIVADENT, INC. 1996-05-09 |