Identity
- Trade Name
- PAPAYA 3D Plus (VOLUX 55) EUDAMEDGenoray FDA UDI
- Generic Name
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
- Device Name
- PAPAYA 3D Plus (VOLUX 55) EUDAMED
- Model / Reference
- 704 EUDAMEDPAPAYA 3D Plus FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809244060243 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809244060243 EUDAMED
- 510(k) Number
- K220392 FDA UDI
- FDA Product Code
- OAS FDA UDIMUH FDA UDI
- EMDN Code
- Z1103030102 EQUIPMENT FOR EXTRAORAL DENTAL RADIOLOGY, DIGITAL EUDAMED
- GMDN Term
- Stationary panoramic/tomographic dental x-ray system, digital FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1750 FDA UDI872.1800 FDA UDI
- Market of Registration
- Spain 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
No
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 Papaya 3D Plus (Volux 55) is a dental X-ray imaging system designed for CBCT, panoramic, cephalometric, and model scanning. This unit provides detailed diagnostic images to support treatment planning, implant procedures, and orthodontic diagnostics.
This device is a Class IIb medical device that is not sterile and is not intended for implantation. It is supplied for professional use in clinical settings and holds FDA 510k and MDD authorizations. The system is identified by reference code 704 and Basic UDI 08809244060243.
Frequently asked questions
What clinical applications is the Papaya 3D Plus designed for?
This system is designed for dental imaging, specifically supporting CBCT, panoramic, cephalometric, and model scanning. These diagnostic images are intended to assist clinicians with treatment planning, implant procedures, and orthodontic diagnostics.
Is the Papaya 3D Plus a sterile or implantable device?
No, the Papaya 3D Plus is not a sterile device and is not intended for implantation. It is a Class IIb medical device designed for professional use in clinical settings to capture diagnostic images.
What are the regulatory authorizations for this imaging system?
The Papaya 3D Plus (Volux 55) holds both FDA 510k and MDD authorizations, confirming it has met the necessary regulatory requirements for its intended use in clinical environments.
How is the device identified for tracking purposes?
The system is identified by the reference code 704 and the Basic UDI 08809244060243. These identifiers are used to maintain accurate records of the device within the regulatory registry.
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. Sources consulted: (PAPAYA 3D) Installation Manual Eng Ver1.5 - CE 2460, GENORAY PAPAYA USER MANUAL Pdf Download | ManualsLib, GenoRay® - PAPAYA 3D Plus - Revolution 32 Technology Group, Papaya 3D Plus from Genoray America Inc. - Dentalcompare.com
Authorization Coverage (2 countries)
Regulatory Authorizations
FDA_510K
FDA_510K
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K220392 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K150354 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809244060243 | Class IIb | Active |
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Manufacturer
- Manufacturer
- GENORAY CO., Ltd.
- EUDAMED SRN
- KR-MF-000021014
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (3)
- EUDAMED 3406ab15-b586-4537-955a-866a78c8a63a 61 fields · synced Sep 23, 2026
- FDA UDI b6306c46-14e4-420c-9181-0bc7497eab78 33 fields · synced May 30, 2026
- FDA 510(k) K220392 1 fields · synced May 18, 2026