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Dentsply LLC, Professional Division

✓ 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 II 1

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

SASaudi ArabiaSFDA

21registered imported devices

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

CACanadaMDALL

43active device licences

Class II 35Class III 8

128 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, 0 510(k), 0 PMA, 25 excluded

Brazil1 confirmed, 14 excluded

Saudi Arabia21 confirmed, 16 excluded

Canada43 confirmed, 21 excluded

Manufacturer names merged into this page: DENTSPLY LLC PROFESSIONAL DIVISION ALSO DBA DENTSPLY PROFESSIONAL · DENTSPLY TULSA DENTAL SPECIALTIES A DIVISION OF DENTSPLY INTERNATIONAL INC · DENTSPLY LLC PROFESSIONAL DIVISION TRADING AS SULTAN HEALTHCARE · DENTSPLY LLC TRADING AS "DENTSPLY PROFESSIONAL" · DENTSPLY PROFESSIONAL · Dentsply Professional

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80196880295	PONTAS CAVITRON	Class II
SA	ME0000012365SFDAA00001	Nupro Disposable Dual Arch Fluoride Trays	—
SA	ME0000004764SFDAA00001	Nupro Dual Arch Fluoride Tray	—
CA	783	ENDOSONIC INSERTS	Class II
CA	2924	CAVITRON PROPHY JET AIR POLISHING PROPHYLAXIS UNIT	Class II
CA	3209	DELTON FS+ FLOWABLE PIT & FISSURE SEALANT WITH FLUORIDE	Class III

Dentsply LLC, Professional Division

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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