Cleared Traditional

K180204 - CranioMaxillofacial Fixation (CMF) Syst...

K180204 is the FDA 510(k) clearance for CranioMaxillofacial Fixation (CMF) Syst... by Visionare, LLC. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 338-day FDA review.

K180204 · Visionare, LLC · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2018
Decision
338d
Days
Class 2
Risk

K180204 is an FDA 510(k) clearance for the CranioMaxillofacial Fixation (CMF) System - CMF Visionare. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Visionare, LLC (Fort Myers, US). The FDA issued a Cleared decision on December 28, 2018 after a review of 338 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: 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.

View all Visionare, LLC devices

Submission Details

510(k) Number K180204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2018
Decision Date December 28, 2018
Days to Decision 338 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
211d slower than avg
Panel avg: 127d · This submission: 338d
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

PaxMed International, LLC
Kevin Thomas

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 156
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