Cleared Special

K240754 - N2

K240754 is an FDA 510(k) clearance for N2, manufactured by Megagen Implant Co., Ltd.. The device is a Class 1 Dental device with product code EIA cleared through the Special 510(k) pathway after a 1-day FDA review.

K240754 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2024
Decision
1d
Days
Class 1
Risk

K240754 is an FDA 510(k) clearance for the N2. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Megagen Implant Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on March 21, 2024 after a review of 1 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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.

FDA 510(k) Submission Details - K240754

510(k) Number K240754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2024
Decision Date March 21, 2024
Days to Decision 1 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d faster than avg
Panel avg: 128d · This submission: 1d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Consultant

Third Party Review Group, LLC
Dave Yungvirt

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.

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All 282
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K240754 · N2
Download PDF FDA Summary Megagen Implant Co., …