FDA · official record K260662Substantially Equivalent

Dental Cone Beam Computed Tomography System

Name: Dental Cone Beam Computed Tomography System — FDA K260662
Creator: Yofo Medical Technology Co., Ltd.
Keywords: Dental Cone Beam Computed Tomography System, Dental Cone Beam Computed Tomography System, K260662, OAS, FDA

United StatesOASYofo Medical Technology Co., Ltd.

Verified

Official record identity

FDA application number: K260662
Decision date: June 04, 2026
Published decision: Substantially Equivalent

Classification

Product code: OAS

Published parties

Applicant: Yofo Medical Technology Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Special
Received date: 2026-03-02
Review panel: Radiology
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 892.1750

About this record

This record preserves an application published in the FDA 510(k) bulk export, including the DEN entries FDA includes in that export. Historical decisions do not establish current marketing status. Product-code harmonization is separate from the original application; joined establishment identifiers are not assigned to the applicant. The complete official export is checked daily and raw evidence is retained.