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Home›Korea, Republic›DENTAL STUDIO COMPANY

DENTAL STUDIO COMPANY

Korea, Republic · Anyang-Si Gyeonggi
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Russia — 3 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
48listed device types
Class I 33Class II 6Class III 0unclassified 9
plus 77 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
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
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
pendingnot queried
RURussiaRoszdravnadzor
9active registrations
Class 1 6Class 2a 3
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 States77 registration records, 1 510(k), 0 PMA, 11 excluded
Brazil3 confirmed, 1 excluded
Manufacturer names merged into this page: DENTAL STUDIO · FIRE DENTAL STUDIO, LLC · GREGORY WEIL DENTAL CERAMIC STUDIO, INC. · MASTER DENTAL STUDIO · DENTAL STUDIO COMPANY
Same-named companies — This database also contains companies with near-identical names: M&M Dental Studio, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Korea, Republic
City
Anyang-Si Gyeonggi

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

12015 · K133088

FDA listed device types

showing 8 of 48
Forceps 1Frame, Rubber Dam 1Positioner, Tooth, Preformed 1Unit, Suction Operatory 1Accessories, Implant, Dental, Endosseous 1Unit, Oral Irrigation 1Material, Impression Tray, Resin 1Elevator, Surgical, Dental 1

Registration details (sample)

MarketIdentifierNameClass / date
USK133088ZX-272015-01-02
BR80724000042FAMILIA DE INSTRUMENTOS NÃO ARTICULADOS E CORTANTES NAO ESTEREISClass I
BR80724000043EASY BONE SCRAPER - KIT COM 5 UNIDADESClass I
BR80724000044FAMILIA DE INSTRUMENTOS NÃO ARTICULADOS E CORTANTESClass I

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