The following data is part of a premarket notification filed by Gc Orthodontics America Inc. with the FDA for Gc Kommonbase.
Device ID | K143667 |
510k Number | K143667 |
Device Name: | GC KommonBase |
Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
Applicant | GC Orthodontics America Inc. 11535 S.Central Avenue Alsip, IL 60803 |
Contact | Tom Macari |
Correspondent | Dr. Mark Heiss GC America Inc. 3737 W. 127th Street Alsip, IL 60803 |
Product Code | DYH |
CFR Regulation Number | 872.3750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-23 |
Decision Date | 2015-05-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
E53590130000001 | K143667 | 000 |
E53590120000001 | K143667 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
GC KOMMONBASE 86388000 4942163 Live/Registered |
Trademark Holdings of Illinois LLC 2014-09-08 |
GC KOMMONBASE 86373512 not registered Dead/Abandoned |
GC Corporation 2014-08-21 |