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GC America, Inc.

USA · Alsip
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
62listed device types
Class I 40Class II 21Class III 0unclassified 1
plus 165 registration records and 130 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
24registered devices
Class I 5Class II 19
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
12active device licences
Class II 8Class III 4
107 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States165 registration records, 130 510(k), 0 PMA, 8 excluded
Brazil24 confirmed, 9 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada12 confirmed, 2 excluded
Manufacturer names merged into this page: GC AMERICA INC. · GC Orthodontics America Inc. · GC America Inc. · GC ORTHODONTICS AMERICA INC.
Same-named companies — This database also contains companies with near-identical names: Gc Orthodontics America, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Alsip

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

62002
42003
62004
72005
12006
72007
112008
42009
32010
32011
22012
22013
42014
42015
72016
42018
22019
52020
32025
32026

FDA listed device types

showing 8 of 62
Pusher, Band, Orthodontic 1Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Syringe, Restorative And Impression Material 1Facebow 1Material, Impression Tray, Resin 1Clasp, Preformed 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253317Cytrans™ Elashield2026-07-06
USK261246SRGC-062026-06-18
USK254109G-CEM UNIVERSAL2026-05-18
BR80034310020Alicates GC Orthodontics AmericaClass I
BR80034319013Braquetes CerâmicosClass II
BR80034319014Fios ortodônticos de aço inoxClass II
CA8725COE LOR RTCClass II
CA11198POUR-N-CUREClass II
CA11700G-CERA ORBIT VESTClass II

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