Cleared Special

K014263 - NEWGEN/UNIVERSAL MANDIBULAR SYSTEM

K014263 is the FDA 510(k) clearance for NEWGEN/UNIVERSAL MANDIBULAR SYSTEM by Stryker Instruments. It is a Class 2 Dental device (product code JEY) cleared through the Special 510(k) pathway after a 71-day FDA review.

K014263 · Stryker Instruments · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2002
Decision
71d
Days
Class 2
Risk

K014263 is an FDA 510(k) clearance for the NEWGEN/UNIVERSAL MANDIBULAR SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on March 8, 2002 after a review of 71 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Stryker Instruments devices

Submission Details

510(k) Number K014263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2001
Decision Date March 08, 2002
Days to Decision 71 days
Submission Type Special
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
56d faster than avg
Panel avg: 127d · This submission: 71d
Pathway characteristics
Modification to existing cleared device.

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 K014263.
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · Synthes (Usa) · May 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002
RESORB-X RESORBABLE PLATING SYSTEM
K011590 · KLS-Martin L.P. · Mar 2002
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002
STRAUMANN GBR SYSTEM
K011698 · Institut Straumann AG · Aug 2001
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001