Palodex Group Oy
Tuusula Uusimaa, FI
PALODEX GROUP OY appears in FDA device records in Tuusula Uusimaa, FI. FDA records list 16 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 7 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
2 namesFDA records resolved to Palodex Group Oy carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Instrumentarium Dental, Inc.510(k), recall
- Instrumentarium Dental, Palodex Group OY510(k), enforcement report, recall
510(k) clearance history
FDA records hold 16 510(k) clearances for Palodex Group Oy between 2007 and 2024. The busiest year on record is 2017, with 4. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 2 |
| 2008 | 1 |
| 2009 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2017 | 4 |
| 2018 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K241249 | Orthopantomograph™ OP 3D LX (PAN 3D); Orthopantomograph™ OP 3D LX (PAN CEPH 3D) | OAS | Substantially Equivalent | |
| K230505 | Orthopantomograph™ OP 3D LX | OAS | Substantially Equivalent | |
| K180947 | Orthopantomograph OP 3D | OAS | Substantially Equivalent | |
| K173646 | FS Ergo | MUH | Substantially Equivalent | |
| K163423 | Orthopantomograph OP300 | OAS | Substantially Equivalent | |
| K162799 | Cliniview | LLZ | Substantially Equivalent | |
| K170813 | ORTHOPANTOMOGRAPH OP 3D | OAS | Substantially Equivalent | |
| K133544 | OP300 | OAS | Substantially Equivalent | |
| K133231 | DIGORA OPTIME | MUH | Substantially Equivalent | |
| K130297 | SCANORA 3DX | OAS | Substantially Equivalent | |
| K122018 | OP300 | OAS | Substantially Equivalent | |
| K093683 | ORTHOPANTOMOGRAPH OP300 | MUH | Substantially Equivalent | |
| K092591 | ORTHOPANTOMOGRAPH OP30 | MUH | Substantially Equivalent | |
| K081925 | SNAPSHOT | MUH | Substantially Equivalent | |
| K063837 | SIGMA M | MUH | Substantially Equivalent | |
| K063773 | VOLUMETRIC TOMOGRAPHY | OAS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005383085 | 3005383085 | PALODEX GROUP OY | NAHKELANTIE 160, Tuusula Uusimaa 04300 FI | 2026 | and 1 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- NHAAbutment, Implant, Dental, Endosseous
- MYNAnalyzer, Medical Image
- QIHAutomated Radiological Image Processing Software
- PNPDental Abutment Design Software For Dental Laboratory
- IWZFilm, Radiographic
- OUGMedical Device Data System
- LLZSystem, Image Processing, Radiological
- NOFSystem, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- MUHSystem, X-Ray, Extraoral Source, Digital
- EHDUnit, X-Ray, Extraoral With Timer
- OASX-Ray, Tomography, Computed, Dental
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2413-2024 | 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 qualified healthcare professionals. | 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%). | Class II | Open, Classified | |
| Z-0842-2020 | Instrumentarium Dental Express 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. | Class II | Terminated | |
| Z-0841-2020 | KaVo Scan eXam 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. | Class II | Terminated | |
| Z-0840-2020 | Gendex GXPS-500 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. | Class II | Terminated | |
| Z-0839-2020 | 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. | Class II | Terminated | |
| Z-1091-2014 | 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 the Sigma USB terminal which is connected to a PC, which reads the image data from a sensor and displays the image on the PC monitor. In order to make installation and service faster and easier the electronics is integrated into the horizontal arm. FOCUS is intended to be used for producing diagnostic x-ray radiographs of dentition, jaws and other oral structures. | 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 may not properly support the unit as expected, which could cause the unit to drift. Depending on the extent of the shortened or missing welds, there is also a possibility that the wall mount unit will fail to support the weight of the unit, resulting in the FOCUS X-ray unit falling unexpectedly from its mounted position. | Class II | Terminated | |
| Z-0816-2007 | 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. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain