DENTIUM CO., LTD.

Korea, Republic · Suwon-Si

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Canada, Taiwan, Singapore, Australia, Israel, 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

7listed device types

Class I 5Class II 2Class III 0

plus 21 registration records and 23 510(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

4active device licences

Class III 4

16 including historic records

TWTaiwanTFDA

9valid device licences

Class I 2Class II 2Class III 5

SGSingaporeHSA SMDR

18device registrations

CLASS B 10CLASS C 8

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

11active ARTG entries

Class I 1IIa 5IIb 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 1Class 2a 4Class 2b 2

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 States21 registration records, 23 510(k), 0 PMA, 3 excluded

Canada4 confirmed, 1 excluded

Manufacturer names merged into this page: DENTIUM CO., LTD.

FDA 510(k) clearances by year

12004

42006

12007

12010

22012

12014

42016

32017

22018

12019

22020

12022

FDA listed device types

Implant, Endosseous, Root-Form 1Abutment, Implant, Dental, Endosseous 1Crown, Preformed 1Accessories, Implant, Dental, Endosseous 1Driver, Band, Orthodontic 1Gauge, Depth, Instrument, Dental 1Chisel, Osteotome, Surgical 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K213599	SuperLine	2022-02-23
US	K193341	iCTmotor (WL-1)	2020-09-04
US	K192436	Healing Abutments and Cover Screws	2020-01-23
CA	85852	DENTIUM IMPLANT SYSTEM - SCREW ABUTMENT	Class III
CA	85854	DENTIUM IMPLANT SYSTEM - TI-RETAINING SCREW	Class III
CA	85855	DENTIUM IMPLANT SYSTEM - ABUTMENT	Class III

DENTIUM 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)

Similar companies