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PALODEX GROUP OY

Finland · Tuusula

✓ 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

11listed device types

Class I 2Class II 9Class III 0

plus 17 registration records and 10 510(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

7active device licences

Class II 4Class III 3

13 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 States17 registration records, 10 510(k), 0 PMA, 2 excluded

Brazil1 confirmed, 0 excluded

Canada7 confirmed, 2 excluded

Manufacturer names merged into this page: PALODEX GROUP OY

FDA 510(k) clearances by year

12012

12013

12014

42017

12018

12023

12024

FDA listed device types

showing 8 of 11

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Dental Abutment Design Software For Dental Laboratory 1System, X-Ray, Extraoral Source, Digital 1Abutment, Implant, Dental, Endosseous 1Unit, X-Ray, Extraoral With Timer 1X-Ray, Tomography, Computed, Dental 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K241249	Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)	2024-09-12
US	K230505	Orthopantomograph OP 3D LX	2023-06-09
US	K180947	Orthopantomograph OP 3D	2018-06-07
BR	10064010249	SISTEMA DE PROCESSAMENTO DE IMAGEM DE PLACAS DIGITAIS INTRAORAL	Class II
CA	86940	GXPS-500	Class II
CA	87179	GXDP-300 (DIGITAL PANORAMIC X-RAY UNIT)	Class II
CA	88297	GXDP-700 (PAN/CEPH/3D)	Class III

PALODEX GROUP OY

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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