GC Orthodontics America Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30100320423010032042GC Orthodontics America Inc.1Y2026-01-013737 W. 127th Street Alsip IL US 60803

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
10860013564701Curva - Lng Handle Uiv Distal End Cutter w/hold+1(888)332-4883GCOAInfo@gcorthodontics.com
10860013564718Curva - Universal Distal End Cutter w/hold+1(888)332-4883GCOAInfo@gcorthodontics.com
10860013564725Curva - Pin & Ligature Cutter, Micro+1(888)332-4883GCOAInfo@gcorthodontics.com
10860013564732Curva - Pin & Ligature Cutter, Standard+1(888)332-4883GCOAInfo@gcorthodontics.com
10860013564756Curva - Weingart Utility Plier+1(888)332-4883GCOAInfo@gcorthodontics.com
10860013564763Curva - Cinch Back Plier+1(888)332-4883GCOAInfo@gcorthodontics.com
10860013564770Curva - Bird Beak Plier+1(888)332-4883GCOAInfo@gcorthodontics.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1528081565222157K150128GC Ortho Connect, GC Ortho Etching GelDYH2015-07-16
1528081359812152K143667GC KommonBaseDYH2015-05-07
1528081616772333K123094ORTHODONTIC CERAMIC BRACKETSNJM2012-12-13
1528081121128510K123092CERAMIN BRACKETS ZNJM2012-12-21
1528081885453503K093749GC AADVA IMPLANT SYSTEMDZE2010-12-06
1528081008207016
1528081017489777
1528081064874815
1528081070771688
1528081092525112
1528081097724268
1528081108137400
1528081141831512
1528081203059609
1528081214420277
1528081230130301
1528081256719243
1528081258705547
1528081304270493
1528081310173238
1528081440796224
1528081512017559
1528081639186912
1528081642071589
1528081698146024
1528081717155010
1528081732029315
1528081853947627
1528081857841080
1528081883043821
1528082034727771
1528082055906733

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYH22015-07-16
NJM22012-12-21
DZE12010-12-06

PMN#

GUDID#

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