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PreXion3D Explorer PRO (P03A/P03B)

EUDAMEDFDA UDIFDA 510(k)

Class IIb (EU MDR)

Ref P03A/P03B

by PreXion Corporation

Identity

Trade Name
PreXion3D Explorer PRO FDA UDI
Generic Name
Cone beam computed tomography system, head/neck FDA UDI
Device Name
PreXion3D Explorer PRO EUDAMED
Model / Reference
P03A/P03B EUDAMED
P03A FDA UDI

Identifiers

Primary DI / UDI-DI
04589557760040 EUDAMEDFDA UDI
Basic UDI-DI
458955776000014W EUDAMED
Direct Marketing DI
04589557760040 EUDAMED
FDA Product Code
OAS FDA UDI
EMDN Code
Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
GMDN Term
Cone beam computed tomography system, head/neck FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
892.1750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

Yes

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

The PreXion3D Explorer PRO (P03A/P03B) is a Class IIb Cone Beam Computed Tomography (CBCT) device, designed for dental imaging. It provides 360° panoramic and 3D volumetric imaging with adjustable field-of-view sizes, including 5×5 cm, 10×10 cm, 15×10 cm, and 15×16 cm, enabling detailed diagnostic evaluations for various dental and maxillofacial applications.

This active, non-sterile, single-use device is intended for use in dental practices and clinics. It operates with low radiation exposure while delivering precise imaging for diagnostics in periodontology, endodontics, implantology, orthodontics, and maxillofacial surgery. Supplied with a UDI (04589557760040), it complies with FDA 510K and MDR regulatory requirements. The device is non-reusable and not implantable, with no latex components.

Frequently asked questions

What types of dental and maxillofacial applications is the PreXion3D Explorer PRO designed to support with its imaging capabilities?

The PreXion3D Explorer PRO is specifically designed for detailed diagnostic evaluations in periodontology, endodontics, implantology, orthodontics, and maxillofacial surgery. Its 360° panoramic and 3D volumetric imaging with adjustable field-of-view sizes (5×5 cm, 10×10 cm, 15×10 cm, and 15×16 cm) allows for precise visualization of dental structures and surrounding tissues, enabling accurate assessments for these specialties.

Is the PreXion3D Explorer PRO reusable, and if not, what does this mean for my practice’s workflow?

No, the PreXion3D Explorer PRO is explicitly designed as a single-use device, meaning each unit is intended for one-time use only. This non-reusable nature simplifies infection control protocols in your practice, as there’s no need for reprocessing or sterilization between patients. However, it does require purchasing replacement units as needed, so inventory management should account for this.

What radiation exposure levels can I expect when using the PreXion3D Explorer PRO for dental imaging?

The device is engineered to deliver low radiation exposure, though exact dose metrics (e.g., effective dose or dose-area product) are not provided in the data. Its design prioritizes minimizing patient and operator radiation while maintaining high-resolution imaging for diagnostics. For precise dose information, consult the device’s technical manual or manufacturer’s safety documentation.

How do I store the PreXion3D Explorer PRO to ensure it remains functional and safe for use?

Since the device is non-sterile and single-use, storage should focus on protecting it from physical damage, contamination, or environmental factors that could compromise its integrity. Store in a clean, dry location away from direct sunlight or extreme temperatures. Avoid exposure to moisture or chemicals. The manufacturer’s guidelines (not provided here) may include specific storage conditions, so verify those before use.

What regulatory pathways has the PreXion3D Explorer PRO followed, and who is the authorized representative in Europe?

The device has undergone FDA 510K clearance and complies with the Medical Device Regulation (MDR) in Europe. In the EU market, the authorized representative is PreXion(Europe) GmbH, registered under SRN *DE-AR-000023607*. For detailed regulatory documentation (e.g., technical files or certification), contact the manufacturer, PreXion Corporation, or the authorized representative directly.

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: PreXion 3D CBCT Explorer PRO | CBCT Scan | PreXion, PreXion 3D Explorer (LP) - PreXion, 3D Explorer Pro | PreXion, Inc. | DPS, PreXion Explorer PRO - Luman Dental

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
PreXion Corporation
EUDAMED SRN
JP-MF-000028222
Authorised Representative
PreXion(Europe)GmbH DE-AR-000023607

Sources (3)

  • EUDAMED fb1d6eca-d5af-4e1c-89d0-52219f1fb73e 61 fields · synced Sep 18, 2026
  • FDA UDI 8c6f9b42-7982-4460-99e8-fc717ba0ada9 32 fields · synced May 30, 2026
  • FDA 510(k) K190320 1 fields · synced May 18, 2026