FDA 510(k) clearance · back to tracker

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

Lakong Medical Devices Co., Ltd. cleared K254009 on 2026-09-10, decision: substantially equivalent

K-number

K254009

Sponsor

Lakong Medical Devices Co., Ltd.

Device

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

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-09-10

Product code

SJH

Advisory committee

Dental

Medical specialty

Dental

Regulation number

872.6640

Official FDA record

Open K254009on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

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Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

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Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.