Cleared Traditional

K251544 - Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)

K251544 is an FDA 510(k) clearance for Dental Unit (MP2000-550LED-2.0, manufactured by Lakong Medical Devices Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 444-day FDA review.

K251544 · Lakong Medical Devices Co., Ltd. · Dental device
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Aug 2026
Decision
444d
Days
Class 1
Risk

K251544 is an FDA 510(k) clearance for the Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0). Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Lakong Medical Devices Co., Ltd. (Dongguan, CN). The FDA issued a Cleared decision on August 7, 2026 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Lakong Medical Devices Co., Ltd. devices

FDA 510(k) Submission Details - K251544

510(k) Number K251544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2025
Decision Date August 07, 2026
Days to Decision 444 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
317d slower than avg
Panel avg: 127d · This submission: 444d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

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.

Regulatory Peers - EIA Unit, Operative Dental

All 171
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