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DENTECH CORPORATION

Japan · Sumas

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, 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

23listed device types

Class I 23Class II 0Class III 0

plus 23 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

3registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

4 including historic records

TWTaiwanTFDA

7valid device licences

Class I 7

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States23 registration records, 2 510(k), 0 PMA, 5 excluded

Brazil1 confirmed, 1 excluded

Saudi Arabia3 confirmed, 0 excluded

Manufacturer names merged into this page: DENTECH CORP. · DENTECH CORPORATION

FDA 510(k) clearances by year

11990 · K896532

11995 · K942870

FDA listed device types

showing 8 of 23

Light, Fiber Optic, Dental 1Frame, Rubber Dam 1Instrument, Hand, Calculus Removal 1Forceps, Articulation Paper 1Accessories, Implant, Dental, Endosseous 1Instrument, Contouring, Matrix, Operative 1Drill, Dental, Intraoral 1Instruments, Dental Hand 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K942870	ULTIMA 2 DENTAL CHAIR	1995-02-27
US	K896532	DENTAL DELIVERY SYSTEM	1990-02-12
BR	80141430167	GRAMPO KSK	Class I
SA	ME0000005557SFDAA00002	DENTAL DAM	—
SA	ME0000005557SFDAA00001	KSK DENTECH	—

DENTECH CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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