Data / Medical devices / Finland / Palodex Group OY

Palodex Group OY: FDA-registered device maker in Tuusula Uusimaa, Finland, 14 510(k) clearances

Name: Palodex Group OY FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Palodex Group OY is registered with the FDA (registration 3005383085) in Tuusula Uusimaa, Finland. It lists 11 device types. The FDA files 14 510(k) clearances under its listings, the newest dated November 17, 2025. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005383085
Address: Nahkelantie 160, Tuusula Uusimaa, Finland, 04300
Owner or operator: PaloDEx Group Oy (9079085)
Roles: Complaint file establishment, Exporter to the US, Manufacturer
First device listed: October 31, 2005
Registered through: 2026
Brand names listed: DIGORA Optime, DTX Studio Assist, DTX Studio Clinic, DTX Studio Core, DTX Studio Diagnose, DTX Studio Implant, DTX Studio Lab, FOCUS and more

Devices it lists

Device	Product code	Class	Role	Source
Abutment, Implant, Dental, Endosseous	NHA	2	Complaint file establishment	accessdata.fda.gov
Analyzer, Medical Image	MYN	2	Complaint file establishment	accessdata.fda.gov
Automated Radiological Image Processing Software	QIH	2	Complaint file establishment	accessdata.fda.gov
Dental Abutment Design Software For Dental Laboratory	PNP	2	Complaint file establishment	accessdata.fda.gov
Film, Radiographic	IWZ	1	Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Complaint file establishment	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Complaint file establishment	accessdata.fda.gov
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations	NOF	2	Exporter to the US	accessdata.fda.gov
System, X-Ray, Extraoral Source, Digital	MUH	2	Manufacturer	accessdata.fda.gov
Unit, X-Ray, Extraoral With Timer	EHD	2	Manufacturer	accessdata.fda.gov
X-Ray, Tomography, Computed, Dental	OAS	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 17, 2025	K252086	DTX Studio Assist	MYN	Substantially Equivalent	Nobel Biocare C/O Medicim NV	accessdata.fda.gov
September 12, 2024	K241249	Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D)	OAS	Substantially Equivalent	Palodex Group OY	accessdata.fda.gov
December 8, 2023	K231898	DTX Studio Clinic (4.0)	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
June 9, 2023	K230505	Orthopantomograph OP 3D LX	OAS	Substantially Equivalent	Palodex Group OY	accessdata.fda.gov
March 25, 2022	K213562	DTX Studio Clinic 3.0	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
November 20, 2020	K203156	DTX Studio Clinic	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
October 8, 2020	K200810	IPS CaseDesigner	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
March 1, 2019	K181932	DTX Studio design	PNP	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
June 7, 2018	K180947	Orthopantomograph OP 3D	OAS	Substantially Equivalent	Palodex Group OY	accessdata.fda.gov
January 11, 2018	K172224	DTX Studio diagnose	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
January 31, 2017	K163122	NobelClinician, DTX Studio implant	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
November 10, 2016	K161634	IPS CaseDesigner	LLZ	Substantially Equivalent	Nobel Biocare AB	accessdata.fda.gov
March 20, 2014	K133231	DIGORA OPTIME	MUH	Substantially Equivalent	Instrumentarium Dental, Palodex Group OY	accessdata.fda.gov
July 13, 2000	K001729	FOCUS	EHD	Substantially Equivalent	Instrumentarium Corp.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
October 28, 2021	95017	Class II	Ongoing	Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projection images for the reconstruction of a 3D view. The device is operated and used by q	It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatability test even when the test result is not within the set acceptance criteria (repeatability within 4%).	accessdata.fda.gov
January 7, 2020	84544	Class II	Terminated	Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)	Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 systems may result in short circuiting which may cause heating and melting. The melting may generate smoke and eventually cause the PSU to fail.	accessdata.fda.gov
January 14, 2014	67342	Class II	Terminated	The FOCUS is a microprocessor controlled intra-oral x-ray unit with a Load Matching Frequency (LMF) DC generator, which produces dental images on digital and film media. For the digital images the FOCUS is connected to t	Instrumentarium Dental has delivered a number of FOCUS 3.0 Intraoral X-ray units in November 2013 with a potential flaw in the mounting hardware. A number of wall mount units were delivered with FOCUS X-ray machines that had not been properly welded at our supplier. As a result of the incomplete welding operation, the wall mount unit on the FOCUS X-ray unit	accessdata.fda.gov
April 28, 2006	37838	Not yet classified	Terminated	Cranex Tome panoramic x-ray unit with Spiral Tomography for cross-sectional imaging. manufactured by SOREDEX, PO Box 250, 00031 Helsinki, Finland.	There may be a material defect in the up/down movement axle of the unit. This may cause the upper part of the unit to suddenly come down.	accessdata.fda.gov

Compare with other makers

Updated November 17, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.