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W&H Dentalwerk Burmoos GmbH

Austria · Burmoos

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada — 4 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

3510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

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

8active device licences

Class II 8

47 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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 States0 registration records, 3 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia3 confirmed, 0 excluded

Canada8 confirmed, 1 excluded

Manufacturer names merged into this page: W&H DENTALWERK BURMOOS GMBH · W&H DENTALWERK BURMOOS G.M.B.H · W&H Dentalwerk Burmoos GmbH

Registration details (sample)

Market	Identifier	Name	Class / date
US	K162926	Air-Powered Handpieces and Handpiece Attachments	2017-02-23
US	K161957	W&H Implantmed SI-1015 incl. Accessories	2016-11-23
US	K041124	IRRIGATION TUBING SET 2.2M AND 3.8M	2004-06-07
BR	80047300763	Unidade de Acionamento para uso em Cirurgia Dentária, Implantologia, C	Class II
BR	80047309195	Scaling, Perio, Restoration, Endo	Class II
BR	80047309158	INSTRUMENTOS DENTÁRIOS	Class II
SA	ME0000001863SFDAA00057	Assistina 301 Plus	—
SA	ME0000001863SFDAA00058	Assistina Twin	—
CA	71596	IDC DISTANCE CONTROL	Class II
CA	71775	BTI DRILLTECH SYSTEM	Class II
CA	71776	INNOVA ISM SYSTEM	Class II

W&H Dentalwerk Burmoos GmbH

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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