Cleared Traditional

K254009 - Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV)

K254009 · Lakong Medical Devices Co., Ltd. · Dental device
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Sep 2026
Decision
269d
Days
-
Risk

K254009 is an FDA 510(k) clearance for the Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV).

Submitted by Lakong Medical Devices Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on September 10, 2026 after a review of 269 days - an extended review cycle.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Lakong Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K254009

510(k) Number K254009 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 2025
Decision Date September 10, 2026
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
141d slower than avg
Panel avg: 128d · This submission: 269d
Pathway characteristics
Predicate-based equivalence.

SJH Device Classification - Class ,

Product Code SJH
Device Class -

Regulatory Consultant

Shanghai CV Technology Co., Ltd.
Doris Dong

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.