Orthopantomograph™ OP 3D LX (PAN 3D) +1 more model
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K241249 FDA 510(k)
- FDA Product Code
- OAS FDA 510(k)
- Models / Variants
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1750 FDA 510(k)
- Regulation Number
- 892.1750 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Orthopantomograph OP 3D LX is a computed dental tomography device designed for capturing panoramic and cephalometric three-dimensional images of the maxillofacial region. It provides detailed volumetric imaging of dental structures, jaws, and surrounding anatomy, supporting diagnostic assessments in radiology.
This device is intended for use in radiology settings and is supplied as a reusable medical instrument. It has received FDA 510(k) clearance under the Traditional pathway, with a decision classification of Substantially Equivalent, and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device operates within Class II regulatory classification and is authorized for multiple registration numbers under the specified regulatory framework.
Frequently asked questions
What types of imaging does the Orthopantomograph OP 3D LX provide, and how does this benefit dental diagnostics?
The Orthopantomograph OP 3D LX captures panoramic and cephalometric three-dimensional images of the maxillofacial region, including detailed volumetric scans of dental structures, jaws, and surrounding anatomy. This 3D capability enhances diagnostic precision by offering comprehensive views for assessing complex cases, such as impacted teeth, bone abnormalities, or pre-surgical planning, compared to traditional 2D imaging.
Is this device reusable or single-use, and what maintenance considerations should be noted?
The Orthopantomograph OP 3D LX is designed as a reusable medical instrument, meaning it is built for repeated use in radiology settings. Since it is not single-use, proper cleaning, sterilization, and maintenance protocols must be followed to ensure patient safety and device longevity, as outlined in the manufacturer’s instructions.
What regulatory pathways has this device undergone, and how does this affect its use in clinical settings?
The device has received FDA 510(k) clearance under the Traditional pathway, classified as *Substantially Equivalent*, and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). It falls under Class II regulatory classification, which means it has undergone rigorous review by the FDA’s Radiology Advisory Committee (RA) to ensure safety and effectiveness for use in radiology departments.
Are there multiple models or configurations of this device, and how do they differ?
The Orthopantomograph OP 3D LX is available in two configurations: PAN 3D (panoramic 3D imaging) and PAN CEPH 3D (panoramic + cephalometric 3D imaging). While both share core 3D imaging capabilities, the PAN CEPH 3D version includes additional cephalometric views, which are useful for orthodontic assessments and craniofacial analysis.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K241249 | Class II | Active |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
Sources (2)
- FDA 510(k) K241249 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026