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SIRONA DENTAL, INC.

USA · Long Island City

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Russia — 9 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

24 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

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

4active ARTG entries

Class I 3IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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

Brazil16 confirmed, 2 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 COMÉRCIO DE PRODUTOS E SISTEMAS ODONTOLÓGICOS LTDA. · Sirona Dental Inc. · Sirona Dental A/S

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

SIRONA DENTAL, INC.

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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