Palodex Group Oy
FDA Regulatory Profile
Palodex Group Oy appears in FDA public data with 5 recalls, 10 510(k) clearances, 5 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2413-2024, Class II) was initiated on October 28, 2021. Its most recent 510(k) clearance was granted on September 12, 2024.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 10
- Inspections
- 5
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2413-2024 | Class II | Orthopantomograph OP300 dental computed tomography x-ray system. The X-ray device produces conven | October 28, 2021 |
| Z-0842-2020 | Class II | Instrumentarium Dental Express SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | January 7, 2020 |
| Z-0839-2020 | Class II | Soredex DIGORA Optime SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | January 7, 2020 |
| Z-0841-2020 | Class II | KaVo Scan eXam SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | January 7, 2020 |
| Z-0840-2020 | Class II | Gendex GXPS-500 SOLID STATE X-RAY IMAGER (FLAT PANEL/DIGITAL IMAGER) | January 7, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K241249 | Orthopantomograph OP 3D LX (PAN 3D); Orthopantomograph OP 3D LX (PAN CEPH 3D) | September 12, 2024 |
| K230505 | Orthopantomograph OP 3D LX | June 9, 2023 |
| K180947 | Orthopantomograph OP 3D | June 7, 2018 |
| K173646 | FS Ergo | December 19, 2017 |
| K163423 | Orthopantomograph OP300 | August 31, 2017 |
| K162799 | Cliniview | April 25, 2017 |
| K170813 | ORTHOPANTOMOGRAPH OP 3D | April 7, 2017 |
| K133544 | OP300 | March 26, 2014 |
| K130297 | SCANORA 3DX | May 29, 2013 |
| K122018 | OP300 | December 10, 2012 |