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DIADENT GROUP INTERNATIONAL

Korea, Republic · Chungcheongbuk-Do

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, 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

22listed device types

Class I 16Class II 6Class III 0

plus 34 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class I 3Class II 4

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

SASaudi ArabiaSFDA

13registered imported devices

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

CACanadaMDALL

11active device licences

Class II 10Class III 1

45 including historic records

TWTaiwanTFDA

24valid device licences

Class I 15Class II 9

SGSingaporeHSA SMDR

12device registrations

CLASS B 12

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

17active ARTG entries

Class I 3IIa 14

HKHong KongMDACS

7valid listings

Class II 7

ILIsraelAMAR

7registrations

RURussiaRoszdravnadzor

6active registrations

Class 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 States34 registration records, 22 510(k), 0 PMA, 2 excluded

Brazil7 confirmed, 0 excluded

Saudi Arabia13 confirmed, 2 excluded

Canada11 confirmed, 1 excluded

Manufacturer names merged into this page: DIADENT GROUP INTERNATIONAL · DiaDent Group International · Diadent Group International

FDA 510(k) clearances by year

12013

22019

102020

22021

22022

12023

42026

FDA listed device types

showing 8 of 22

Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Material, Tooth Shade, Resin 1Crown And Bridge, Temporary, Resin 1Resin, Root Canal Filling 1Agent, Tooth Bonding, Resin 1Point, Paper, Endodontic 1Plugger, Root Canal, Endodontic 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261166	DIA-CEM	2026-07-09
US	K261093	DIAFIL	2026-06-02
US	K261071	DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)	2026-05-19
BR	80330460009	PONTAS DE GUTTA PERCHA FRX	Class II
BR	80330460008	PONTAS DE PAPEL ABSORVENTE FRX	Class I
BR	80352500013	GUTTA PERCHA	Class II
SA	ME0000011710SFDAA00001	DIA KONDENSOR	—
SA	ME0000011710SFDAA00002	Barbed Broaches	—
CA	65286	DIAPEX	Class III
CA	83152	DIA-PEN	Class II
CA	96324	DIA-PT FILE	Class II

DIADENT GROUP INTERNATIONAL

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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