GC KommonBase

Adhesive, Bracket And Tooth Conditioner, Resin

GC Orthodontics America Inc.

The following data is part of a premarket notification filed by Gc Orthodontics America Inc. with the FDA for Gc Kommonbase.

Pre-market Notification Details

Device IDK143667
510k NumberK143667
Device Name:GC KommonBase
ClassificationAdhesive, Bracket And Tooth Conditioner, Resin
Applicant GC Orthodontics America Inc. 11535 S.Central Avenue Alsip,  IL  60803
ContactTom Macari
CorrespondentDr. Mark Heiss
GC America Inc. 3737 W. 127th Street Alsip,  IL  60803
Product CodeDYH  
CFR Regulation Number872.3750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-23
Decision Date2015-05-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
E53590130000001 K143667 000
E53590120000001 K143667 000

Trademark Results [GC KommonBase]

Mark Image

Registration | Serial
Company
Trademark
Application Date
GC KOMMONBASE
GC KOMMONBASE
86388000 4942163 Live/Registered
Trademark Holdings of Illinois LLC
2014-09-08
GC KOMMONBASE
GC KOMMONBASE
86373512 not registered Dead/Abandoned
GC Corporation
2014-08-21

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