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Dentsply Sirona, Inc.

USA · York

✓ Record-verifiedregistrations found in 5 markets

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

49listed device types

Class I 28Class II 20Class III 0unclassified 1

plus 74 registration records and 86 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

12registered devices

Class I 4Class II 8

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

45active device licences

Class II 45

81 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States74 registration records, 86 510(k), 0 PMA, 6 excluded

Brazil12 confirmed, 3 excluded

Saudi Arabia1 confirmed, 5 excluded

Canada45 confirmed, 2 excluded

Manufacturer names merged into this page: DENTSPLY SIRONA INC · Dentsply Sirona Orthodontics Inc. · DENTSPLY SIRONA ORTHODONTICS INC. ATA DENTSPLY GAC INTERNATIONAL · DENTSPLY SIRONA ORTHODONTICS INC. · DENTSPLY LLC PROFESSIONAL DIVISION ALSO DBA DENTSPLY SIRONA · DENTSPLY SIRONA ORTHODONTICS, INC.

Same-named companies — This database also contains companies with near-identical names: DENTSPLY LLC PROFESSIONAL DIVISION ALSO DBA DENTSPLY SIRONA, DENTSPLY SIRONA ORTHODONTICS, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Business registration

Legal name: DENTSPLY SIRONA Inc.
CIK: 0000818479
Registration status: Active
Listing status: Listed (XRAY)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

72016

102017

82018

92019

112020

52021

62022

42023

82024

122025

62026

FDA listed device types

showing 8 of 49

Pusher, Band, Orthodontic 1Handpiece, Air-Powered, Dental 1Evacuator, Oral Cavity 1Unit, Operative Dental 1Positioner, Tooth, Preformed 1Accessories, Implant, Dental, Endosseous 1Handpiece, Belt And/Or Gear Driven, Dental 1Material, Impression Tray, Resin 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260785	DS Core CBCT Anatomy	2026-04-23
US	K260722	SureSmile Aligner (ASSY500020)	2026-04-15
US	K253565	SureSmile Software	2026-03-04
BR	80196880232	ESSIX PLASTICS	Class II
BR	80196880440	SureSmile Aligner	Class I
BR	80034310017	Braquetes Metálico Dentsply Sirona	Class II
SA	ME0000003856SFDAA00001	Purevac HVE	—
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 Sirona, Inc.

Registrations by market

How these numbers were verified

Company information

Business registration

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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