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G & H Wire Company

USA · Franklin

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel — 9 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

21listed device types

Class I 19Class II 2Class III 0

plus 24 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

9registered devices

Class I 4Class II 5

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

SASaudi ArabiaSFDA

5registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

6valid device licences

Class I 6

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

10active ARTG entries

IIa 10

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

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 States24 registration records, 2 510(k), 0 PMA, 10 excluded

Brazil9 confirmed, 2 excluded

Saudi Arabia5 confirmed, 0 excluded

Canada0 confirmed, 2 excluded

Manufacturer names merged into this page: G & H Wire Company · G&H WIRE COMPANY

FDA 510(k) clearances by year

11996 · K961754

12008 · K081393

FDA listed device types

showing 8 of 21

Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Material, Impression Tray, Resin 1Spring, Orthodontic 1Instruments, Dental Hand 1Accessories, Retractor, Dental 1Handle, Instrument, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K081393	ORTHODONTIC TEMPORARY ANCHORAGE IMPLANT SCREW	2008-08-21
US	K961754	SAFETY RELEASE MODULE	1996-07-10
BR	80328810003	FAMÍLIA DE FIOS ORTODÔNTICOS DE AÇO INOXIDÁVEL	Class II
BR	80328810018	Molas Ortodônticas Flexy NiTi	Class II
BR	80328810019	Colboloy	Class II
SA	ME0000003229SFDAA00002	Orthodontic Tubes	—
SA	ME0000003218SFDAA00121	G&H Orthodontics Hooks	—

G & H Wire Company

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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