Home›GC Orthodontics Europe GmbH

GC Orthodontics Europe GmbH

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Israel, Russia — 6 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

37listed device types

Class I 28Class II 9Class III 0

plus 41 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

22registered devices

Class I 1Class II 21

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

11registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

2active device licences

Class II 2

18 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 2a 1

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 States41 registration records, 2 510(k), 0 PMA, 10 excluded

Brazil22 confirmed, 8 excluded

Saudi Arabia11 confirmed, 0 excluded

Canada2 confirmed, 2 excluded

Manufacturer names merged into this page: GC Orthodontics America Inc. · GC EUROPE N.V. · GC ORTHODONTICS AMERICA INC. · GC Europe N.V. · GC Orthodontics Europe GmbH

FDA 510(k) clearances by year

22015 · K150128

FDA listed device types

showing 8 of 37

Pusher, Band, Orthodontic 1Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Syringe, Restorative And Impression Material 1Facebow 1Clasp, Preformed 1Setter, Band, Orthodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150128	GC Ortho Connect, GC Ortho Etching Gel	2015-07-16
US	K143667	GC KommonBase	2015-05-07
BR	80034310020	Alicates GC Orthodontics America	Class I
BR	80034319013	Braquetes Cerâmicos	Class II
BR	80034319014	Fios ortodônticos de aço inox	Class II
SA	ME0000012878SFDAA00007	ORTHODONTIC METAL TUBE	—
SA	ME0000012878SFDAA00021	GC Ties	—
CA	10736	GC STELLAVEST	Class II
CA	11704	GC PROVITEC	Class II

GC Orthodontics Europe GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies