Cleared Traditional

MCI - CMF System (K182758) - FDA 510(k) Clearance

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

K182758 · Mci Medical Concept Innovation, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
433d
Days
Class 2
Risk

K182758 is an FDA 510(k) clearance for the MCI - CMF System. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Mci Medical Concept Innovation, Inc. (Sunrise, US). The FDA issued a Cleared decision on December 5, 2019 after a review of 433 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Mci Medical Concept Innovation, Inc. devices

Submission Details

510(k) Number K182758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date December 05, 2019
Days to Decision 433 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
306d slower than avg
Panel avg: 127d · This submission: 433d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Consultant

Passarini Regulatory Affairs of America, LLC
Janine Treter

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 - JEY Plate, Bone

All 95
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K182758.
Stryker Customized Mandible Recon Plate Kit
K193136 · Stryker · Mar 2020
Stryker Facial iD Plating System
K193143 · Stryker · Mar 2020
Depuy Synthes Maxillofacial Portfolio - MR Conditional
K192655 · Synthes USA Products, LLC · Dec 2019
KLS Martin Individual Patient Solutions
K191028 · KLS-Martin L.P. · Nov 2019
Stryker Surgeon iD Mandible Recon Plate
K190696 · Stryker · Jun 2019
Delphos Implants Rigid Fixation System
K182609 · Delphos Implants - Ind.Com. Importacao E Exportacao DE · Mar 2019