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Great Lakes Orthodontics, Ltd.

USA · Tonawanda

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 4 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

26listed device types

Class I 16Class II 9Class III 0unclassified 1

plus 30 registration records and 15 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

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

1active device licences

Class II 1

27 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 2

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 States30 registration records, 15 510(k), 0 PMA, 1 excluded

Brazil1 confirmed, 2 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Great Lakes Dental Technologies, Ltd. · GREAT LAKES NEUROTECHNOLOGIES INC. · BMS GREAT LAKES LLC · GREAT LAKES DENTAL TECHNOLOGIES · LAKE ERIE WHOLESALE MEDICAL SUPPLY, DBA GREAT LAKES MEDICAL TRADING · GREAT LAKES ORTHODONTIC LTD.

Same-named companies — This database also contains companies with near-identical names: Great Lakes Bioscience, Great Lakes Dental Technologies, Ltd., Great Lakes Intl., GREAT LAKES ORTHODONTIC LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21983

21984

11985

11986

11987

11993

11994

32004

12009

12016

12018

FDA listed device types

showing 8 of 26

Instruments, Dental Hand 1Wax, Dental, Intraoral 1Bur, Dental 1Positioner, Tooth, Preformed 1Tray, Fluoride, Disposable 1Accessories, Retractor, Dental 1Tray, Impression, Preformed 1Cleanser, Denture, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172765	Smart Moves Complete	2018-06-01
US	K150702	Exceed Tx	2016-03-24
US	K083479	BIOCRYL X	2009-02-27
BR	80601260004	CONJUNTO RETRATOR ODONTOLÓGICO NOLA	Class I
CA	79503	STAINLESS STEEL WIRE	Class II

Great Lakes Orthodontics, Ltd.

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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