Cleared Traditional

K192614 - Meg-Ball Attachment System

K192614 is the FDA 510(k) clearance for Meg-Ball Attachment System by Megagen Implant Co., Ltd.. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 143-day FDA review.

K192614 · Megagen Implant Co., Ltd. · Dental device
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Feb 2020
Decision
143d
Days
Class 2
Risk

K192614 is an FDA 510(k) clearance for the Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet 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. (Daegu, KR). The FDA issued a Cleared decision on February 13, 2020 after a review of 143 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 K192614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2019
Decision Date February 13, 2020
Days to Decision 143 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
16d slower than avg
Panel avg: 127d · This submission: 143d
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 463
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K192614.
Rodo Abutment System
K193274 · Rodo Medical, Inc. · Feb 2020
Luna Dental Implant System- Healing Abutment
K200189 · Shinhung Mst Co., Ltd. · Feb 2020
UCLA CCM Abutment
K192263 · Dio Corporation · Feb 2020
Elos Accurate Hybrid Base
K191919 · Elos Medtech Pinol A/S · Feb 2020
Elos Accurate Customized Abutment
K191890 · Elos Medtech Pinol A/S · Feb 2020
TruAbutment DS
K183106 · Truabutment, Inc. · Jan 2020