Orthopantomograph OP 3D Pro
EUDAMEDFDA UDIFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- ORTHOPANTOMOGRAPH™ OP 3D Pro EUDAMEDORTHOPANTOMOGRAPH OP 3D Pro FDA UDI
- Generic Name
- Limited-view-field CT system FDA UDI
- Device Name
- ORTHOPANTOMOGRAPH™ OP 3D Pro EUDAMED
- Model / Reference
- OP300-1 EUDAMEDFDA UDI901006 EUDAMED
Identifiers
- Catalog Number
- 901006 FDA UDI
- Primary DI / UDI-DI
- 06430035872770 EUDAMEDFDA UDI
- Basic UDI-DI
- B-06430035872770 EUDAMED
- 510(k) Number
- K133544 FDA UDI
- FDA Product Code
- OAS FDA UDI
- EMDN Code
- Z11030507 TOMOGRAPHS EUDAMED
- GMDN Term
- Limited-view-field CT system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI
- Market of Registration
- Finland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Orthopantomograph OP 3D Pro is a computed dental tomography device designed for capturing panoramic and three-dimensional radiographic images of the maxillofacial region. It falls under the nomenclature code Z11030507 and is classified as a Class IIb medical device, enabling detailed visualization of dental structures, jawbones, and surrounding anatomy for diagnostic purposes in radiology.
This non-sterile, non-reusable device is intended for use in dental and maxillofacial imaging settings. Supplied as a standalone system, it operates under FDA 510K clearance and MDD authorization, with a model reference code of OP300-1. The device is not implantable, does not involve medicinal products, or require latex precautions. Its UDI includes the basic identifier B-06430035872770, and it is regulated under the OpenFDA classification for computed dental tomography.
Frequently asked questions
What types of imaging does the Orthopantomograph OP 3D Pro provide, and how does this benefit dental diagnostics?
The Orthopantomograph OP 3D Pro captures both panoramic and three-dimensional radiographic images of the maxillofacial region. This dual capability allows clinicians to visualize dental structures, jawbones, and surrounding anatomy in detail, improving diagnostic accuracy for conditions like impacted teeth, bone abnormalities, or pre-surgical planning.
Is the Orthopantomograph OP 3D Pro designed for single-use or repeated use in a clinical setting?
The device is explicitly non-reusable, as indicated by the 'REUSABLE: 0' field. This means it is intended for use in a single procedure or session before disposal, ensuring patient safety and compliance with non-reusable medical device standards.
What regulatory pathways has the Orthopantomograph OP 3D Pro followed, and what does this mean for its use in the U.S.?
The device has obtained FDA 510K clearance and MDD authorization, confirming it meets U.S. and European regulatory standards for computed dental tomography. The 'decision_description: Substantially Equivalent' and 'clearance_type: Special' indicate it was reviewed by the FDA’s Radiology Advisory Committee (RA) and deemed equivalent to a predicate device, ensuring its safety and effectiveness for use in dental and maxillofacial imaging.
How is the Orthopantomograph OP 3D Pro supplied, and what should clinicians consider regarding its storage?
The device is supplied as a standalone system, non-sterile, and non-reusable. Since it is not sterile, it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures. Proper handling and maintenance are essential to preserve its functionality for diagnostic imaging.
Are there any special precautions or considerations for clinicians using the Orthopantomograph OP 3D Pro, such as latex or medicinal product interactions?
The device does not require latex precautions ('LATEX: 0') and is not associated with medicinal products ('MEDICINAL_PRODUCT: 0'). Additionally, it is not implantable ('IMPLANTABLE: 0') or derived from animal tissues ('ANIMAL_TISSUES: 0'), so clinicians do not need to account for these factors when integrating it into their workflow.
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
FDA_510K
FDA_510K
FDA_510K
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K163423 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K180947 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K170813 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K133544 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K122018 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-06430035872770 | Class IIb | Active |
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Manufacturer
- Manufacturer
- PaloDEx Group Oy
- EUDAMED SRN
- FI-MF-000004943
Sources (3)
- EUDAMED 9eb400bf-88f1-4a79-bdd0-a2b1c4b600bb 85 fields · synced Sep 18, 2026
- FDA UDI af4d6da3-c33b-435f-bb50-d12207140084 35 fields · synced May 30, 2026
- FDA 510(k) K163423 1 fields · synced May 18, 2026