Cleared Traditional

K091679 - LEFORTE SYSTEM BONE PLATE

K091679 is the FDA 510(k) clearance for LEFORTE SYSTEM BONE PLATE by Jeil Medical Corporation. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 115-day FDA review.

K091679 · Jeil Medical Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
115d
Days
Class 2
Risk

K091679 is an FDA 510(k) clearance for the LEFORTE SYSTEM BONE PLATE. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Jeil Medical Corporation (Salt Lake City, US). The FDA issued a Cleared decision on October 2, 2009 after a review of 115 days - within the typical 510(k) review window.

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. 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 Jeil Medical Corporation devices

Submission Details

510(k) Number K091679 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2009
Decision Date October 02, 2009
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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 Peers - JEY Plate, Bone

All 156
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K091679.
SYNTHES DENTOALVEOLAR BONE FIXATION SYSTEM
K102656 · Synthes (Usa) · Dec 2010
SUSTAIN SPACE MAINTENANCE SYSTEM
K100779 · Medtronic Sofamor Danek USA, Inc. · Dec 2010
SYNTHES MATRIXMANDIBLE SUBCONDYLAR PLATES
K091233 · Synthes (Usa) · Dec 2009
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
K091144 · Synthes (Usa) · Aug 2009
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
K083388 · Synthes (Usa) · Mar 2009
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM
K082335 · Synthes (Usa) · Nov 2008