Cleared Traditional

K160536 - Chaorum Implant System

K160536 is an FDA 510(k) clearance for Chaorum Implant System, manufactured by Medimecca Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 314-day FDA review.

K160536 · Medimecca Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
314d
Days
Class 2
Risk

K160536 is an FDA 510(k) clearance for the Chaorum Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Medimecca Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on January 5, 2017 after a review of 314 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K160536

510(k) Number K160536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 26, 2016
Decision Date January 05, 2017
Days to Decision 314 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
186d slower than avg
Panel avg: 128d · This submission: 314d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

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 Consultant

LK Consulting Group USA, Inc.
PRISCILLA CHUNG

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.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K160536.
GMI Frontier Dental Implant System
K161593 · Ilerimplant S.L · Jan 2017
SuperLine
K160965 · Dentium Co., Ltd. · Jan 2017
Dentalis Bio Solution Implants
K161281 · Dentalis Bio Solution Implants, LLC · Jan 2017
Ritter Dental Implant System
K160475 · Ritter Implants GmbH CO KG · Dec 2016
s-Clean OneQ-SL Narrow Implant System
K161244 · Dentis Co., Ltd. · Dec 2016
Zeramex P6 Dental Implant System
K163043 · Dentalpoint AG · Nov 2016