Cleared Traditional

K181477 - MS Lide Implant Systems

K181477 is the FDA 510(k) clearance for MS Lide Implant Systems by Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 868-day FDA review.

K181477 · Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. · Dental device
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Oct 2020
Decision
868d
Days
Class 2
Risk

K181477 is an FDA 510(k) clearance for the MS Lide Implant Systems. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. (Hangzhou, CN). The FDA issued a Cleared decision on October 20, 2020 after a review of 868 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. devices

Submission Details

510(k) Number K181477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2018
Decision Date October 20, 2020
Days to Decision 868 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
741d slower than avg
Panel avg: 127d · This submission: 868d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Consultant

Manton Business and Technology Services
Charles Shen

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 - DZE Implant, Endosseous, Root-form

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