FDA · official record K260367Substantially Equivalent

Portable Dental X-ray System Model PDX nova

Name: Portable Dental X-ray System Model PDX nova — FDA K260367
Creator: PDX Co., Ltd.
Keywords: Portable Dental X-ray System Model PDX nova, Portable Dental X-ray System Model PDX nova, K260367, EHD, FDA

United StatesEHDPDX Co., Ltd.

Verified

Official record identity

FDA application number: K260367
Decision date: May 27, 2026
Published decision: Substantially Equivalent

Classification

Product code: EHD

Published parties

Applicant: PDX Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2026-02-04
Review panel: Dental
Current product-code class (harmonized): 2
Current product-code regulation (harmonized): 872.1800

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.