Dental Cone Beam Computed Tomography System

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Yofo

Model / Reference

YOFO-PIROX-S

Primary DI / UDI-DI

06974778410146

Basic UDI-DI

697477841DentalCBCT2N

510(k) Number

K243337 ↗

FDA Product Code

OAS

EMDN Code

Z1103030102 Equipment for extraoral dental radiology, digital

Device Class

Class IIb EUDAMED

Class II 510(k)

Regulation

21 CFR Part 892.1750

EU market of registration

Germany

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Yofo

  Class IIb

  CE/MDR

• Dental Cone Beam Computed Tomography System

  Class II

  FDA 510(k) K260662 Active Cleared 4 Jun 2026

• What types of clinical settings is this Dental Cone Beam Computed Tomography System designed for, and how does its portability benefit users?

  This system is specifically designed for dental and radiology clinics, where detailed 3D imaging of dental structures, maxillofacial anatomy, and surrounding bone is required. Its portability allows for easy integration into existing workflows, reducing the need for specialized rooms and enabling flexibility in patient care settings.

• Is this device single-use or reusable, and what does that mean for maintenance and cleaning procedures?

  The device is not single-use—it is intended for reusable professional use in controlled environments. This means it must be regularly maintained, cleaned, and serviced according to manufacturer guidelines to ensure safety, performance, and compliance with regulatory standards like FDA 510(k) and MDR.

• How many model variants are registered for this system, and what does that imply about customization or compatibility?

  Multiple model variants are registered (listed under OpenFDA registration numbers), each corresponding to specific configurations or software versions. This suggests the system offers flexibility to match different clinical needs, such as varying field-of-view sizes or imaging protocols, while ensuring compatibility with existing workflows.

• Does this device require sterilization, and if not, what precautions should be taken during use?

  Sterility is not applicable for this reusable device, as it is designed for professional use in controlled environments. However, proper disinfection and maintenance protocols must still be followed to prevent cross-contamination between patients, adhering to clinical best practices and regulatory expectations.

• What regulatory pathways does this device follow, and how does that affect its use in different markets?

  The system is cleared under FDA 510(k) and compliant with MDR (Medical Device Regulation), classifying it as a Class II device under 21 CFR 892.1750. This means it has undergone rigorous review for safety and effectiveness, ensuring it meets U.S. and EU standards for dental imaging devices, though specific market requirements (e.g., labeling, documentation) may vary by jurisdiction.