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DENTOS, INCORPORATED

Korea, Republic · Daegu

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Singapore, 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

12listed device types

Class I 10Class II 2Class III 0

plus 12 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

6 including historic records

TWTaiwanTFDA

4valid device licences

Class I 3Class III 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 1Class 2b 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 States12 registration records, 2 510(k), 0 PMA

Manufacturer names merged into this page: DENTOS, INCORPORATED · DENTOS INC.

FDA 510(k) clearances by year

12006 · K060126

12019 · K181142

FDA listed device types

showing 8 of 12

Spring, Orthodontic 1Wax, Dental, Intraoral 1Bit, Drill 1Forceps, Dressing, Dental 1Clamp, Wire, Orthodontic 1Plier, Orthodontic 1Driver, Band, Orthodontic 1Bracket, Metal, Orthodontic 1

Market	Identifier	Name	Class / date
US	K181142	Absoanchor Microimplant	2019-02-05
US	K060126	ABSOANCHOR MICROIMPLANT	2006-05-16

DENTOS, INCORPORATED

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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