Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Dentsply SironaLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Palodex Group Oy with 10 510(k) clearances and 5 device recalls. The most recent is a 510(k) clearance dated Sep 12, 2024: Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Sep 12, 2024 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D)K241249 · OAS | 510(k) clearances |
| Jun 9, 2023 | Orthopantomograph™ OP 3D LXK230505 · OAS | 510(k) clearances |
| Oct 28, 2021 | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conventional 2D X-ray images and Xray projectClass II · It was noticed in production on 28.10.2021, that the final testing database gives a pass result for Pan ADC repeatabilit | Device recalls |
| Jan 7, 2020 | Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II · Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 system | Device recalls |
| Jan 7, 2020 | Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II · Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 system | Device recalls |
| Jan 7, 2020 | Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II · Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 system | Device recalls |
| Jan 7, 2020 | KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER)Class II · Slow degradation of plastic insulation used in the PSU DC plug of the DIGORA Optime, Scan eXam, Express, GXPS-500 system | Device recalls |
| Jun 7, 2018 | Orthopantomograph OP 3DK180947 · OAS | 510(k) clearances |
| Dec 19, 2017 | FS ErgoK173646 · MUH | 510(k) clearances |
| Aug 31, 2017 | Orthopantomograph OP300K163423 · OAS | 510(k) clearances |
| Apr 25, 2017 | CliniviewK162799 · LLZ | 510(k) clearances |
| Apr 7, 2017 | ORTHOPANTOMOGRAPH OP 3DK170813 · OAS | 510(k) clearances |
| Mar 26, 2014 | OP300K133544 · OAS | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
