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SIRONA DENTAL SYSTEMS GMBH

Germany · Bensheim

✓ Record-verifiedregistrations found in 11 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 11 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

43listed device types

Class I 21Class II 20Class III 0unclassified 2

plus 115 registration records and 42 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 11Class II 5

19 including historic records

SASaudi ArabiaSFDA

44registered imported devices

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

CACanadaMDALL

40active device licences

Class II 26Class III 14

81 including historic records

TWTaiwanTFDA

22valid device licences

Class I 9Class II 13

SGSingaporeHSA SMDR

35device registrations

CLASS B 19CLASS C 16

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

38active ARTG entries

Class I 15IIa 15IIb 8

HKHong KongMDACS

10valid listings

Class II 4Class III 6

ILIsraelAMAR

34registrations

RURussiaRoszdravnadzor

43active registrations

Class 1 7Class 2a 28Class 2b 8

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 States115 registration records, 42 510(k), 0 PMA, 7 excluded

Brazil16 confirmed, 3 excluded

Saudi Arabia44 confirmed, 1 excluded

Canada40 confirmed, 3 excluded

Manufacturer names merged into this page: SIRONA DENTAL SYSTEMS GMBH · Sirona Dental Systems GmbH · SIRONA DENTAL, INC. · Sirona Dental Inc. · Sirona Dental A/S · SIRONA Dental Systems GmbH

FDA 510(k) clearances by year

21998

21999

22000

32001

42003

22004

22005

52006

42008

12009

12010

22011

12012

52013

12014

42015

12016

FDA listed device types

showing 8 of 43

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Implant, Endosseous, Root-Form 1Unit, X-Ray, Extraoral With Timer 1Light-Induced Fluorescence Caries Detector 1System, Image Processing, Radiological 1Activator, Ultraviolet, For Polymerization 1Abutment, Implant, Dental, Endosseous 1Material, Impression 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160099	CEREC SpeedGlaze	2016-06-02
US	K151045	TENEO Dental Treatment Unit and Accessories	2015-07-24
US	K150909	INTEGO Family and Accesories	2015-07-17
BR	80745400027	CEREC Guide 2	Class I
BR	80745400003	SISTEMA DE AQUISIÇÃO DE IMAGENS PARA RESTAURAÇÃO CEREC AC	Class I
BR	80745400028	CEREC ZIRCÔNIA	Class II
SA	ME0000003450SFDAA00001	Nitram Oil#2	—
SA	ME0000000597SFDAA00093	Cerec Guide Drill Key Set	—
CA	14264	ACCUDEXA BMD ASSESSMENT SYSTEM	Class III
CA	67079	SDX DIGITAL DENTAL X-RAY UNIT	Class II
CA	67080	CDR PANX DIGITAL PANORAMIC X-RAY UNIT	Class II