DIO Corporation

Korea, Republic · Busan

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Russia — 7 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

18listed device types

Class I 12Class II 6Class III 0

plus 37 registration records and 14 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class I 2Class II 1

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

5active device licences

Class II 1Class III 4

31 including historic records

TWTaiwanTFDA

17valid device licences

Class I 7Class II 5Class III 5

SGSingaporeHSA SMDR

6device registrations

CLASS B 3CLASS C 3

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

31active ARTG entries

Class I 16IIa 7IIb 7Class Im (measuring) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

5active registrations

Class 1 1Class 2a 1Class 2b 2Class 3 1

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, 14 510(k), 0 PMA, 6 excluded

Brazil3 confirmed, 1 excluded

Canada5 confirmed, 0 excluded

Manufacturer names merged into this page: DIO Corporation · DIO CORPORATION

FDA 510(k) clearances by year

12010

12011

12013

12017

42018

12019

32020

12021

12023

FDA listed device types

showing 8 of 18

System, Image Processing, Radiological 1Additively Manufactured, Preformed, Resin Denture Tooth 1Resin, Denture, Relining, Repairing, Rebasing 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Abutment, Implant, Dental, Endosseous 1Implant, Endosseous, Root-Form 1Attachment, Precision, All 1Handpiece, Water-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220253	Eco Abutment, Multiunit Abutment	2023-08-18
US	K210828	DIOnavi-Denture02	2021-03-23
US	K193623	DIOnavi-Denture	2020-10-22
BR	10388870014	COMPONENTES DE MOLDAGEM GLOBTEK	Class I
BR	10388870020	BROCAS CIRÚRGICAS GLOBTEK	Class II
BR	10388870021	CHAVE DIGITAL GLOBTEK	Class I
CA	78973	UCLA GOLD ABUTMENT	Class III
CA	92567	PROTEM IMPLANTS	Class III
CA	93036	DIO IMPLANT SYSTEM	Class III

DIO Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies