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Dentsply International, Inc.

USA · York

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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

72510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 72 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class II 1

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

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

88active device licences

Class II 36Class III 52

153 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, 72 510(k), 0 PMA, 22 excluded

Brazil1 confirmed, 14 excluded

Saudi Arabia0 confirmed, 21 excluded

Canada88 confirmed, 20 excluded

Manufacturer names merged into this page: DENTSPLY SIRONA ORTHODONTICS INC. ATA DENTSPLY GAC INTERNATIONAL · DENTSPLY INTERNATIONAL INC. ALSO TRADING AS: DENTSPLY AUSTENAL · DENTSPLY NEW IMAGE DENTSPLY INTERNATIONAL · DENTSPLY TULSA DENTAL SPECIALTIES A DIVISION OF DENTSPLY INTERNATIONAL INC · DENTSPLY INTERNATIONAL INC

Registration details (sample)

Market	Identifier	Name	Class / date
US	K160207	ATLANTIS ISUS Implant Suprastructures	2016-09-21
US	K160232	Disposable Barrier Sleeves and Covers	2016-06-07
US	K151439	ATLANTIS ISUS	2016-02-19
BR	80196880356	ProTaper Next® Conform FitTM Gutta-Percha	Class II
CA	1157	IDEAL ZINC PHOSPHATE BAND CEMENT	Class II
CA	1158	WATERCEM GLASS IONOMER CEMENT	Class II
CA	1163	SMARTBOND ORTHODONTIC ADHESIVE	Class II

Dentsply International, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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