Cleared Traditional

TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM (K951689) - FDA 510(k) Clearance

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

K951689 · Medicon EG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
113d
Days
Class 2
Risk

K951689 is an FDA 510(k) clearance for the TITANIUM MANDIBULAT RECONSTRUCTION SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Medicon EG (Black Diamond, US). The FDA issued a Cleared decision on July 27, 1995 after a review of 113 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 Medicon EG devices

Submission Details

510(k) Number K951689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1995
Decision Date July 27, 1995
Days to Decision 113 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 127d · This submission: 113d
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 96
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K951689.
SYNTHES 2.4 MM UNIVERSAL LOCKING PLATE SYSTEM
K961421 · Synthes (Usa) · Jun 1996
SYNTHES (USA) MIDFACIAL SYSTEM
K953806 · Synthes (Usa) · Mar 1996
SYNTHES MANDIBULAR MODULAR FIXATION SYSTEM
K954385 · Synthes (Usa) · Mar 1996
LUHR MANDIBULAR/SMALL FIXATION IMPLANTS
K950595 · Howmedica Corp. · Jul 1995
AESCULAP CRANIOFACIAL TITANIUM PLATES AND SCREWS
K923705 · Aesculap, Inc. · Feb 1994
LUHR MICRO MESH
K901940 · Howmedica Corp. · Sep 1990