Cleared Traditional

K231967 - ARi ExCon Implant System

K231967 is the FDA 510(k) clearance for ARi ExCon Implant System by Megagen Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K231967 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2023
Decision
157d
Days
Class 2
Risk

K231967 is an FDA 510(k) clearance for the ARi ExCon Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Deagu, KR). The FDA issued a Cleared decision on December 7, 2023 after a review of 157 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

Submission Details

510(k) Number K231967 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2023
Decision Date December 07, 2023
Days to Decision 157 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
30d slower than avg
Panel avg: 127d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K231967.
ZENEX Implant System_Short
K233163 · Izenimplant Co., Ltd. · Dec 2023
S-Plant Dental Implant System
K231429 · Idis Co., Ltd. · Dec 2023
S.I.N. Dental Implant System
K231127 · S.I.N. ? Sistema DE Implante Nacional S.A. · Dec 2023
Single Platform SP1 Implant System
K232418 · Southern Implants (Pty), Ltd. · Dec 2023
Neodent Implant System - GM Zygomatic Implant System
K232099 · JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A. · Oct 2023
UNIdental Symphony Implant System
K221315 · Unidental Co., Ltd. · Oct 2023