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Durr Dental AG

Germany · Bietigheim-Bissingen

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Saudi Arabia, Canada, Singapore, Australia, Israel — 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

10listed device types

Class I 4Class II 6Class III 0

plus 15 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

0active device licences

2 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

6device registrations

CLASS B 6

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

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 States15 registration records, 11 510(k), 0 PMA, 1 excluded

Saudi Arabia1 confirmed, 0 excluded

Manufacturer names merged into this page: DURR DENTAL SE · Durr Dental SE

FDA 510(k) clearances by year

22016

12018

22019

12020

22021

22023

12025

FDA listed device types

showing 8 of 10

Unit, Operative Dental, Accessories 1Evacuator, Oral Cavity 1Film, Radiographic 1Holder, Film, X-Ray 1Light-Induced Fluorescence Caries Detector 1Light Transmission Caries Detector 1System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250947	VistaSoft 4.0 and VisionX 4.0	2025-08-27
US	K232487	Provecta 3D Prime and Provecta 3D Prime Ceph	2023-09-14
US	K230095	ScanX Swift 2.0, ScanX Swift View 2.0	2023-02-06
SA	ME0000001687SFDAA00001	Hygosonic	—

Durr Dental AG

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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