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Home›Belgium›DENTSPLY IMPLANTS NV

DENTSPLY IMPLANTS NV

Belgium · Hasselt
✓ 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
9listed device types
Class I 4Class II 5Class III 0
plus 50 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
32registered devices
Class I 20Class II 12
37 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
18active device licences
Class II 13Class III 5
61 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 States50 registration records, 2 510(k), 0 PMA, 21 excluded
Brazil32 confirmed, 12 excluded
Saudi Arabia0 confirmed, 21 excluded
Canada18 confirmed, 26 excluded
Manufacturer names merged into this page: Dentsply Implants Manufacturing GmbH · DENTSPLY Implants N.V. · DENTSPLY IMPLANTS MANUFACTURING GMBH · DENTSPLY IMPLANTS NV · DENTSPLY IMPLANTS MANUFACTURING GMBH (HANAU)
Same-named companies — This database also contains companies with near-identical names: Dentsply Implants Manufacturing GmbH. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Belgium
City
Hasselt

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.

FDA 510(k) clearances by year

22013 · K130999

FDA listed device types

showing 8 of 9
Accessories, Implant, Dental, Endosseous 1Blade, Saw, General & Plastic Surgery, Surgical 1Instrument, Cutting, Operative 1Chisel, Osteotome, Surgical 1System, Image Processing, Radiological 1Plate, Bone 1Dental Abutment Design Software For Dental Laboratory 1Abutment, Implant, Dental, Endosseous 1

Registration details (sample)

MarketIdentifierNameClass / date
USK130999OSSEOSPEED PROFILE EV2013-10-25
USK130216ATLANTIS STRAUMANN BONE LEVEL ABUTMENT2013-05-01
BR80196880384Instrumentais Cirúrgicos Manuais Não-Estéreis Uso Único de Aço inoxidáClass II
BR80196880380Componentes Protéticos Metal-Plástico Uso ÚnicoClass II
BR80196880216FAMÍLIA DE INSTRUMENTOS PROTÉTICOSClass I
CA70607ANKYLOS PROSTHETIC KIT, COMPLETEClass II
CA70608ANKYLOS 2ND STAGE SURGERY KIT, COMPLETEClass II
CA70915ANKYLOS SURGERY KIT FOR (M) A, B IMPLANTSClass II

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