Cleared Traditional

K230618 - MegaGen Dental Implant Systems Portfolio - MR Conditional

K230618 is an FDA 510(k) clearance for MegaGen Dental Implant Systems Portfoli..., 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 219-day FDA review.

K230618 · Megagen Implant Co., Ltd. · Dental device
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Oct 2023
Decision
219d
Days
Class 2
Risk

K230618 is an FDA 510(k) clearance for the MegaGen Dental Implant Systems Portfolio - MR Conditional. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on October 11, 2023 after a review of 219 days - an extended review cycle.

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 - K230618

510(k) Number K230618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 2023
Decision Date October 11, 2023
Days to Decision 219 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
92d slower than avg
Panel avg: 127d · This submission: 219d
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 Peers - DZE Implant, Endosseous, Root-form

All 1182
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