Cleared Traditional

K233450 - MegaGen Dental Implant Abutment - Scan Healing Abutment (FDA 510(k) Clearance)

Also includes:
Temporary Abutment Temporary Cylinder Comfort Cap Healing Cap Healing Cap Screw Milling Abutment EZ Post Abutment Extra EZ Post Abutment EZ Post Cylinder ZrGEN Abutment Multi-unit Abutment Multi-unit Angled Abutment AXA Abutment (Straight) AXA Abutment (Angled) Abutment Screw Cylinder Screw Crown Screw

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233450 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2024
Decision
94d
Days
Class 2
Risk

K233450 is an FDA 510(k) clearance for the MegaGen Dental Implant Abutment - Scan Healing Abutment. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on January 22, 2024 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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

Submission Details

510(k) Number K233450 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 2023
Decision Date January 22, 2024
Days to Decision 94 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
33d faster than avg
Panel avg: 127d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 701
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K233450.
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