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DENTSPLY LIMITED

USA · Weybridge

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Russia — 5 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

62listed device types

Class I 31Class II 28Class III 0unclassified 3

plus 167 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class II 12

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

SASaudi ArabiaSFDA

1registered imported devices

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

CACanadaMDALL

3active device licences

Class II 3

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

1active registrations

Class 2a 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 States167 registration records, 0 510(k), 0 PMA, 24 excluded

Brazil12 confirmed, 14 excluded

Saudi Arabia1 confirmed, 20 excluded

Canada3 confirmed, 27 excluded

Manufacturer names merged into this page: DENTSPLY LLC · DENTSPLY LIMITED · Dentsply Ltd

FDA listed device types

showing 8 of 62

Alloy, Amalgam 1Additively Manufactured, Preformed, Resin Denture Tooth 1Solid State X-Ray Imager (Flat Panel/Digital Imager) 1Mask, Surgical 1Unit, X-Ray, Intraoral 1Collimator, Manual, Radiographic 1Unit, X-Ray, Extraoral With Timer 1Sealant, Pit And Fissure, And Conditioner 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80745409008	Palodent® 360 - Kit de sistema completo com Palodent® V3	Class II
BR	80196880335	Dentsply Sirona Universal Stain and Glaze Kit	Class II
BR	80745409027	Lucitone Digital Fuse Step 3	Class II
SA	ME0000009129SFDAA00001	DISPOSASHIELD	—
CA	65597	DENTAL BURS-STEEL	Class II
CA	65598	DENTAL BURS-CARBIDE	Class II
CA	65762	DENTAL BURS - DIAMOND	Class II

DENTSPLY LIMITED

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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