Cleared Traditional

K150537 - MiNi Internal Implant System

K150537 is an FDA 510(k) clearance for MiNi Internal Implant System, manufactured by Megagen Implant Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K150537 · Megagen Implant Co., Ltd. · Dental device
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Jul 2015
Decision
140d
Days
Class 2
Risk

K150537 is an FDA 510(k) clearance for the MiNi Internal Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Gyeongsan-Si, KR). The FDA issued a Cleared decision on July 21, 2015 after a review of 140 days - within the typical 510(k) review window.

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: 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 Megagen Implant Co., Ltd. devices

FDA 510(k) Submission Details - K150537

510(k) Number K150537 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2015
Decision Date July 21, 2015
Days to Decision 140 days
Submission Type Traditional
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
13d slower than avg
Panel avg: 127d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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

Kodent, Inc.
MEGAN HOLD

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

All 1173
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K150537.
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