HomeUSADENTSPLY SIRONA ORTHODONTICS, INC.

DENTSPLY SIRONA ORTHODONTICS, INC.

USA · Sarasota
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 10 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
11valid device licences
Class I 10Class II 1
SGSingaporeHSA SMDR
3device registrations
CLASS B 3
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
9active ARTG entries
Class I 7IIb 2
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
6registrations
RURussiaRoszdravnadzor
2active registrations
Class 1 1Class 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 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, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Sarasota

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

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)

MarketIdentifierNameClass / date
USK260785DS Core CBCT Anatomy2026-04-23
USK260722SureSmile Aligner (ASSY500020)2026-04-15
USK253565SureSmile Software2026-03-04
BR80196880232ESSIX PLASTICSClass II
BR80196880440SureSmile AlignerClass I
BR80034310017Braquetes Metálico Dentsply SironaClass II
SAME0000003856SFDAA00001Purevac HVE
CA1157IDEAL ZINC PHOSPHATE BAND CEMENTClass II
CA1158WATERCEM GLASS IONOMER CEMENTClass II
CA1163SMARTBOND ORTHODONTIC ADHESIVEClass II

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