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SIRONA DENTAL COMÉRCIO DE PRODUTOS E SISTEMAS ODONTOLÓGICOS LTDA.

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in Brazil, Saudi Arabia, Canada — 3 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

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

6 including historic records

SASaudi ArabiaSFDA

3registered imported devices

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

CACanadaMDALL

4active device licences

Class II 3Class III 1

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, 0 510(k), 0 PMA, 10 excluded

Brazil1 confirmed, 3 excluded

Saudi Arabia3 confirmed, 4 excluded

Canada4 confirmed, 4 excluded

Manufacturer names merged into this page: SIRONA DENTAL, INC. · SIRONA DENTAL COMÉRCIO DE PRODUTOS E SISTEMAS ODONTOLÓGICOS LTDA. · Sirona Dental Inc. · Sirona Dental A/S

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80712530001	SISTEMA DE RADIOGRAFIA DIGITAL INTRA-ORAL	Class I
SA	ME0000003450SFDAA00001	Nitram Oil#2	—
SA	ME0000011838SFDAA00001	Xios XG USB- Interface	—
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 COMÉRCIO DE PRODUTOS E SISTEMAS ODONTOLÓGICOS LTDA.

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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