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Dentaurum GmbH & Co. KG

Germany · Ispringen

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

49listed device types

Class I 41Class II 8Class III 0

plus 54 registration records and 10 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

38registered devices

Class I 11Class II 27

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

16active device licences

Class II 7Class III 9

48 including historic records

TWTaiwanTFDA

11valid device licences

Class I 4Class II 6Class III 1

SGSingaporeHSA SMDR

3device registrations

CLASS B 3

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

15active ARTG entries

Class I 6IIa 7IIb 2

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

3registrations

RURussiaRoszdravnadzor

8active registrations

Class 1 3Class 2a 5

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 States54 registration records, 10 510(k), 0 PMA

Brazil38 confirmed, 0 excluded

Canada16 confirmed, 1 excluded

Manufacturer names merged into this page: Dentaurum GmbH & Co. KG · DENTAURUM GMBH & CO. KG · DENTAURUM · DENTAURUM GMBH&CO.KG · DENTAURUM GMBH & CO KG.

FDA 510(k) clearances by year

22001

52003 · K030644

12005 · K042965

22006 · K062733

FDA listed device types

showing 8 of 49

Pusher, Band, Orthodontic 1Aligner, Bracket, Orthodontic 1Positioner, Tooth, Preformed 1Band, Preformed, Orthodontic 1Facebow 1Accessories, Implant, Dental, Endosseous 1Clasp, Preformed 1Drill, Dental, Intraoral 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K062733	TOMAS PIN SD 6, 8, AND 10 MM	2006-11-09
US	K062732	TOMAS PIN 6 MM	2006-10-25
US	K042965	TOMAS PIN	2005-04-15
BR	10241250007	EXPANSOR DE DILATACAO OU DE TRACAO DENTAURUM	Class II
BR	10241250011	COMPONENTES PARA ORTODONTIA	Class II
BR	10241250012	FIO E ARCO ORTODONTICO DENTAURUM	Class II
CA	8978	LOCKPINS	Class II
CA	10720	CASTING ALLOYS - TI (FOR BRIDGES AND CROWNS)	Class III
CA	27458	CASTING ALLOYS - NICR (FOR BRIDGES AND CROWNS)	Class III