Cleared Traditional

K131289 - I-GEN

K131289 is an FDA 510(k) clearance for I-GEN, manufactured by Megagen Implant Co., Ltd.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K131289 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2013
Decision
142d
Days
Class 2
Risk

K131289 is an FDA 510(k) clearance for the I-GEN. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Brea, US). The FDA issued a Cleared decision on September 25, 2013 after a review of 142 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 - K131289

510(k) Number K131289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2013
Decision Date September 25, 2013
Days to Decision 142 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
15d slower than avg
Panel avg: 127d · This submission: 142d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 248
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K131289.
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