Cleared Special

K202039 - Honorst Implant System

K202039 is the FDA 510(k) clearance for Honorst Implant System by Medimecca Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Special 510(k) pathway after a 64-day FDA review.

K202039 · Medimecca Co., Ltd. · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
64d
Days
Class 2
Risk

K202039 is an FDA 510(k) clearance for the Honorst Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Medimecca Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on September 25, 2020 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medimecca Co., Ltd. devices

Submission Details

510(k) Number K202039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2020
Decision Date September 25, 2020
Days to Decision 64 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 127d · This submission: 64d
Pathway characteristics
Modification to existing cleared device.

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

LK Consulting Group USA, Inc.
Priscilla Chung

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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