The following data is part of a premarket notification filed by Gc America Inc. with the FDA for Everx Posterior.
Device ID | K153127 |
510k Number | K153127 |
Device Name: | EverX Posterior |
Classification | Material, Tooth Shade, Resin |
Applicant | GC AMERICA INC. 3737 W. 127TH STREET Alsip, IL 60803 |
Contact | Mark Heiss |
Correspondent | Mark Heiss GC AMERICA INC. 3737 W. 127TH STREET Alsip, IL 60803 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-10-29 |
Decision Date | 2016-05-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() EVERX POSTERIOR 85779574 not registered Dead/Abandoned |
GC Corporation 2012-11-14 |