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DENTSPLY DETREY GmbH

Germany · Konstanz

✓ 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

10listed device types

Class I 3Class II 7Class III 0

plus 18 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

4registered devices

Class II 4

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

SASaudi ArabiaSFDA

14registered imported devices

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

CACanadaMDALL

14active device licences

Class II 3Class III 11

29 including historic records

TWTaiwanTFDA

18valid device licences

Class I 1Class II 17

SGSingaporeHSA SMDR

11device registrations

CLASS B 11

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

18active ARTG entries

Class I 9IIa 9

HKHong KongMDACS

1valid listings

Class II 1

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

16active registrations

Class 2a 16

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 States18 registration records, 0 510(k), 0 PMA, 1 excluded

Brazil4 confirmed, 0 excluded

Saudi Arabia14 confirmed, 0 excluded

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: DENTSPLY DETREY GmbH · DENTSPLY DETREY GMBH · DENTSPLY DETREY GMBH RADOLFZELL OPERATION CENTER (ROC) · DENTSPLY DeTrey · Dentsply DeTrey GmbH

FDA listed device types

showing 8 of 10

Activator, Ultraviolet, For Polymerization 1Cement, Dental 1Resin, Denture, Relining, Repairing, Rebasing 1Dental Barriers And Sleeves 1Material, Tooth Shade, Resin 1Resin, Root Canal Filling 1Agent, Tooth Bonding, Resin 1Applicator, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10186370111	SELANTE AH PLUS	Class II
BR	80196889051	Prime&Bond One ETCH & RINSE	Class II
BR	80196880427	Neo Spectra ST	Class II
SA	ME0000001656SFDAA00001	Palodent 360 circumferential Matrix system	—
SA	ME0000001656SFDAA00002	DeTrey Conditioner 36 Applicator Needles	—
CA	1841	PRIME & BOND NT	Class III
CA	1949	DYRACT AP	Class III
CA	2043	DYRACT SEAL	Class III

DENTSPLY DETREY GmbH

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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