Cleared Traditional

K082335 - SYNTHES MATRIXMANDIBLE PLATE AND SCREW ...

K082335 is the FDA 510(k) clearance for SYNTHES MATRIXMANDIBLE PLATE AND SCREW ... by Synthes (Usa). It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K082335 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2008
Decision
88d
Days
Class 2
Risk

K082335 is an FDA 510(k) clearance for the SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Synthes (Usa) (West Chester, US). The FDA issued a Cleared decision on November 10, 2008 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Synthes (Usa) devices

Submission Details

510(k) Number K082335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date November 10, 2008
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
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 K082335.
LEFORTE SYSTEM BONE PLATE
K091679 · Jeil Medical Corporation · Oct 2009
SYNTHES MATRIXMANDIBLE PREFORMED RECONSTRUCTION PLATES
K091144 · Synthes (Usa) · Aug 2009
SYNTHES MATRIXORTHOGNATHIS FIXATION SYSTEM
K083388 · Synthes (Usa) · Mar 2009
SONICWELD RX (RESORB-X)
K080862 · KLS-Martin L.P. · Jul 2008
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM
K080331 · Synthes (Usa) · Apr 2008
MODUS TRILOCK 2.0/2.3/2.5
K071612 · Medartis AG · Sep 2007