Manufacturer registered with FDA
PaloDEx Group Oy
TUUSULA, Finland. Lists 6 dental device types with FDA across 1 registered establishment, and holds 9 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 9
- 510(k) clearances
- 92012–2024
- Markets registered in
- 12130 registrations outside the US
- Establishments
- 1Finland
510(k) clearances per year, 2007–2026
Registered in 12 markets
Where regulators' registries name PaloDEx Group Oy as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | PaloDEx Group Oy | 9 clearances | 2012–2024 | Below |
| European Union | EUDAMED | Manufacturer | PaloDEx Group Oy | 45 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | PALODEX GROUP OY | 27 | 2002–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | PaloDEx Group Oy | 18 | 2011–2023 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Palodex Group OyPaloDEx Group Oy | 9 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PALODEX GROUP OY | 9 | 2010–2018 | Pure Global AI |
| China | NMPA | Registration holder | 帕罗德斯有限责任公司PaloDEx Group OyPaloDEx Group Oy帕罗德斯有限责任公司 · 帕罗德斯有限责任公司 PaloDEx Group Oy | 5 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | PaloDEx Group Oy | 5 | 2024–2024 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | PaloDEx Group Oy | 4 | 2026–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | PaloDEx Group Oy | 4 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | PaloDEx Group OyPaloDEx Group Oy, | 3 | 2013–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PALODEX GROUP OY | 1 | 2018–2018 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What PaloDEx Group Oy currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | ORTHOPANTOMOGRAPH OP 3DOrthopantomograph OP 3D EXOrthopantomograph OP 3D EXOrthopantomograph OP 3D LXOrthopantomograph OP 3D LX | 2018 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | FOCUS | 2005 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | DIGORA Optime | 2014 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Lister | DTX Studio Lab | 2023 |
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Lister | — | 2019 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Lister | DTX Studio Lab | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names PaloDEx Group Oy as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Sep 2024 | K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | OAS Dental Computed Tomography X-Ray |
| 9 Jun 2023 | K230505 | Orthopantomograph OP 3D LX | OAS Dental Computed Tomography X-Ray |
| 7 Jun 2018 | K180947 | Orthopantomograph OP 3D | OAS Dental Computed Tomography X-Ray |
| 19 Dec 2017 | K173646 | FS Ergo | MUH Digital Extraoral Source X-Ray System |
| 31 Aug 2017 | K163423 | Orthopantomograph OP300 | OAS Dental Computed Tomography X-Ray |
| 7 Apr 2017 | K170813 | ORTHOPANTOMOGRAPH OP 3D | OAS Dental Computed Tomography X-Ray |
| 26 Mar 2014 | K133544 | OP300 | OAS Dental Computed Tomography X-Ray |
| 29 May 2013 | K130297 | SCANORA 3DX | OAS Dental Computed Tomography X-Ray |
| 10 Dec 2012 | K122018 | OP300 | OAS Dental Computed Tomography X-Ray |
Also lists devices cleared under other names
PaloDEx Group Oy lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Nobel Biocare Services AG (1), Instrumentarium Dental, Palodex Group OY (1), Instrumentarium Corp. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Mar 2019 | K181932 | DTX Studio design | Nobel Biocare Services AG | PNP Dental Abutment Design Software for Dental Laboratory |
| 20 Mar 2014 | K133231 | DIGORA OPTIME | Instrumentarium Dental, Palodex Group OY | MUH Digital Extraoral Source X-Ray System |
| 13 Jul 2000 | K001729 | FOCUS | Instrumentarium Corp. | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| PALODEX GROUP OYFDA reg. 3005383085 | Tuusula Uusimaa, Finland | Complaint file establishment, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9079085). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.