Cleared Traditional

Magicore II System (K192197) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192197 · Innobiosurg Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2020
Decision
259d
Days
Class 2
Risk

K192197 is an FDA 510(k) clearance for the Magicore II System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Innobiosurg Co., Ltd. (Daejeon, KR). The FDA issued a Cleared decision on April 28, 2020 after a review of 259 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 Innobiosurg Co., Ltd. devices

Submission Details

510(k) Number K192197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2019
Decision Date April 28, 2020
Days to Decision 259 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
132d slower than avg
Panel avg: 127d · This submission: 259d
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 Consultant

Withus Group, Inc.
April Lee

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K192197.
NUVO IF Implant System
K193234 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Jun 2020
S.I.N. Dental Implant System
K193096 · S.I.N. ? Sistema DE Implante Nacional S.A. · May 2020
ZAGA Zygomatic System
K192651 · Southern Implants (Pty), Ltd. · May 2020
Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants
K193592 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2020
Implantswiss Dental Implant System and Implantswiss Dental Abutment System
K200867 · Novodent SA · Apr 2020
s-Clean SQ-SL Implant System Mini
K200099 · Dentis Co., Ltd. · Apr 2020