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THE ARGEN CORPORATION

USA · San Diego

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Taiwan, South Korea, Australia — 5 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

14listed device types

Class I 5Class II 8Class III 0unclassified 1

plus 55 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

0active device licences

13 including historic records

TWTaiwanTFDA

13valid device licences

Class I 1Class II 12

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

4active ARTG entries

IIa 4

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 States55 registration records, 11 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 1 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: THE ARGEN CORPORATION · The Argen Corporation

FDA 510(k) clearances by year

12007

12014

22015

12016

12018

32019

12020

12024

FDA listed device types

showing 8 of 14

Resin, Denture, Relining, Repairing, Rebasing 1Alloy, Metal, Base 1Abutment, Implant, Dental, Endosseous 1Alloy, Gold-Based Noble Metal 1Powder, Porcelain 1Crown And Bridge, Temporary, Resin 1Alloy, Other Noble Metal 1Aligner, Sequential 1

Market	Identifier	Name	Class / date
US	K242458	ArgenZ MTZ	2024-10-24
US	K192846	Argen Clear Aligner, Argen Clear Aligner Premium	2020-02-10
US	K183229	Argen Clear Aligner	2019-06-07

THE ARGEN CORPORATION

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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