HomeKorea, RepublicSURE DENT CORPORATION

SURE DENT CORPORATION

Korea, Republic · Seongnam-Si
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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
6listed device types
Class I 4Class II 1Class III 0unclassified 1
plus 7 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
6registered devices
Class I 1Class II 5
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
6valid device licences
Class I 6
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
11active ARTG entries
Class I 2IIa 9
HKHong KongMDACS
2valid listings
Class II 2
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 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 States7 registration records, 0 510(k), 0 PMA, 8 excluded
Brazil6 confirmed, 3 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: SURE DENT CORPORATION

Company information

Country
Korea, Republic
City
Seongnam-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 listed device types

Preparer, Root Canal Endodontic 1Accessories, Retractor, Dental 1Point, Paper, Endodontic 1Gutta-Percha 1Resin, Root Canal Filling 1Cord, Retraction 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80801639010GutaperchaClass II
BR80801639011Ponta de PapelClass II
BR80104140013Cones de PapelClass II

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