HomeKorea, RepublicDentalmax Co., Ltd.

Dentalmax Co., Ltd.

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

This company has registrations in United States, Brazil, Canada, Australia, Israel, 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
1listed device types
Class I 0Class II 1Class III 0
plus 3 registration records and 3 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
2registered devices
Class II 2
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
2 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIa 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States3 registration records, 3 510(k), 0 PMA
Brazil2 confirmed, 0 excluded
Manufacturer names merged into this page: DENTALMAX CO., LTD · DENTALMAX CO., LTD. · DENTALMAX CO.,LTD

Company information

Country
Korea, Republic
City
Cheonan-Si

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

12018 · K171585
12021 · K212548
12024 · K241151

FDA listed device types

Powder, Porcelain 1

Registration details (sample)

MarketIdentifierNameClass / date
USK241151LUXEN 5G2024-09-30
USK212548LUXEN CL Dental Liquid2021-12-06
USK171585LUXEN Zr, LUXEN Smile2018-10-31
BR83084449001Luxen CLClass II
BR83084449002Luxen 5GClass II

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