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Ortho Solutions Sdn Bhd

Malaysia · Prai Penang Pulau Pinang

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Taiwan — 3 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

87listed device types

Class I 60Class II 27Class III 0

plus 122 registration records and 13 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

8registered devices

Class I 1Class II 7

11 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

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 States122 registration records, 13 510(k), 0 PMA, 104 excluded

Brazil8 confirmed, 34 excluded

Saudi Arabia0 confirmed, 12 excluded

Canada0 confirmed, 13 excluded

Manufacturer names merged into this page: Ortho Solutions LC · Ortho Solutions UK Limited · Ortho Solutions Sdn Bhd · Ortho Solutions Inc · ORTHO SOLUTIONS LC DBA DYNAFLEX · ORTHO SOLUTIONS UK LTD.

FDA 510(k) clearances by year

22011

32012

12014

12017

12020

12021

22024

22025

FDA listed device types

showing 8 of 87

Pusher, Band, Orthodontic 1Forceps 1Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment 1Template 1Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Toothbrush, Manual 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252625	The Response Ortho Smart Fixator - Hexapod System	2025-11-20
US	K250622	Succession AFN System	2025-08-07
US	K241769	Response Ortho Metaphyseal Hinge Fixator System	2024-09-18
BR	80027099002	PLACA GLACIER LTR	Class II
BR	80027099003	PLACA GLACIER ULTRA PREMIUM	Class II
BR	80218010045	Instrumentais para Grampos de Memória Ortho Solutions	Class II

Ortho Solutions Sdn Bhd

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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