HomeKorea, RepublicDENTIS CO., LTD.

DENTIS CO., LTD.

Korea, Republic · Daegu
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Saudi Arabia, Taiwan, Australia, Russia — 6 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
9listed device types
Class I 3Class II 6Class III 0
plus 42 registration records and 37 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
8valid device licences
Class I 4Class III 4
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
28active ARTG entries
Class I 17IIa 8IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
4active registrations
Class 1 1Class 2a 1Class 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 States42 registration records, 37 510(k), 0 PMA, 1 excluded
Brazil1 confirmed, 0 excluded
Saudi Arabia2 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: DENTIS CO., LTD. · Dentis Co.,Ltd · DENTIS CO, LTD · Dentis Co Ltd

Company information

Country
Korea, Republic
City
Daegu

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12008
22009
12012
22015
32016
32017
12018
22020
62021
12022
92023
42024
12025
12026

FDA listed device types

showing 8 of 9
Screw, Fixation, Intraosseous 1Abutment, Implant, Dental, Endosseous 1Crown And Bridge, Temporary, Resin 1Aligner, Sequential 1Implant, Endosseous, Root-Form 1Drill, Bone, Powered 1Accessories, Implant, Dental, Endosseous 1Accessories, Retractor, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253493Dentis SQ-SL AXEL Fixture2026-03-04
USK241065ChecQ (AC100)2025-03-21
USK233921Luvis Chair (LC700C)2024-09-06
BR10351890021Resina Zenith 3DClass II
SAME0000006341SFDAA00001Luminaire for Diagnosis
SAME0000013874SFDAA00001Surgical light, Examination Light

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