FDA · official record K254009Substantially Equivalent

Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

Name: Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) — FDA K254009
Creator: Lakong Medical Devices Co., Ltd.
Keywords: Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV), Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV), K254009, SJH, FDA

United StatesSJHLakong Medical Devices Co., Ltd.

Verified

Official record identity

FDA application number: K254009
Decision date: September 10, 2026
Published decision: Substantially Equivalent

Classification

Product code: SJH

Published parties

Applicant: Lakong Medical Devices Co., Ltd.

Additional source fields

Decision code: SESE
Published decision: Substantially Equivalent
Submission type: Traditional
Received date: 2025-12-15
Review panel: Dental
Current product-code class (harmonized): 1
Current product-code regulation (harmonized): 872.6640

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.