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WUXI TP ORTHODONTICS MATERIAL CO., LTD.

China · Wuxi Jiangsu

✓ Record-verifiedregistrations found in 3 markets

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

pendingnot queried

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

27listed device types

Class I 23Class II 4Class III 0

plus 37 registration records and 5 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

23registered devices

Class I 4Class II 19

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

10active device licences

Class II 10

33 including historic records

TWTaiwanTFDA

pendingnot queried

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 States37 registration records, 5 510(k), 0 PMA, 1 excluded

Brazil23 confirmed, 0 excluded

Canada10 confirmed, 0 excluded

Manufacturer names merged into this page: TP ORTHODONTICS, INC. · WUXI TP ORTHODONTICS MATERIAL CO., LTD. · TP ORTHODONTICS INC · TP ORTHODONTICS APPLIANCE (WUXI) CO.LTD. · TP ORTHODONTICS INC.

Same-named companies — This database also contains companies with near-identical names: TP ORTHODONTICS, INC., TP ORTHODONTICS APPLIANCE (WUXI) CO.LTD.. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21995 · K952643

12011 · K111234

12020 · K193385

12022 · K214054

FDA listed device types

showing 8 of 27

Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Syringe, Restorative And Impression Material 1Material, Impression Tray, Resin 1Retainer, Screw Expansion, Orthodontic 1Spring, Orthodontic 1Instruments, Dental Hand 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K214054	TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520	2022-10-14
US	K193385	TP Orthodontics Clear Aligner System	2020-11-12
US	K111234	CLICK-IT	2011-05-13
BR	10431530038	TUBOS MOLARES TP ORTHODONTICS	Class II
BR	10431530037	ELASTÔMEROS TP ORTHODONTICS	Class II
BR	10431530048	SHINEY BRIGHT	Class II
CA	76208	DENTALOY WIRES	Class II
CA	76209	TUBES - COBALT CHROMIUM	Class II
CA	76247	AUXILIARIES - BRASS	Class II

WUXI TP ORTHODONTICS MATERIAL CO., 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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