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ORTHO ORGANIZERS, INC.

USA · Savannah

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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

40listed device types

Class I 34Class II 5Class III 0unclassified 1

plus 51 registration records and 8 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

31registered devices

Class I 8Class II 23

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

12active device licences

Class II 11Class III 1

81 including historic records

TWTaiwanTFDA

6valid device licences

Class I 5Class II 1

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

Import 2

AUAustraliaTGA ARTG

28active ARTG entries

Class I 10IIa 15Class Im (measuring) 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 1Class 2a 6

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 States51 registration records, 8 510(k), 0 PMA

Brazil31 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada12 confirmed, 0 excluded

Manufacturer names merged into this page: ORTHO ORGANIZERS, INC. · ORTHO ORGANIZERS INC. · ORTHO ORGANIZERS, INC · Ortho Organizers, Inc.

FDA 510(k) clearances by year

31993 · K923218

12006 · K061266

12011 · K110335

12016 · K160720

12018 · K173440

12025 · K252760

FDA listed device types

showing 8 of 40

Bracket, Ceramic, Orthodontic 1Headgear, Extraoral, Orthodontic 1Material, Impression 1Aligner, Sequential 1Bracket, Plastic, Orthodontic 1Pusher, Band, Orthodontic 1Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252760	Carriere® Motion Pro® Clear Bite Corrector	2025-11-27
US	K173440	Carriere SLX 3D Clear	2018-03-08
US	K160720	Carriere Motion Clear Class II	2016-11-28
BR	80027090022	bracket sapphire neocrystal plus	Class II
BR	80027090023	Carriere Motion Force Elastics Clear	Class I
BR	80027090009	Arcos, Fios e Molas para ortodontia - Titanium	Class II
SA	ME0000001579SFDAA00159	Tempra Etch First Molar Band	—
CA	63435	SUPER-C ORTHO ADHESIVE	Class II
CA	63637	PLASTIC GOLD SLOT ORTHODONTIC BRACKETS	Class II
CA	63641	GOLD STAINLESS STEEL ORTHODONTIC BRACKETS	Class II

ORTHO ORGANIZERS, INC.

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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