Cleared Traditional

K013672 - BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM

K013672 is an FDA 510(k) clearance for BRUGES DISTRACTION - ANCHORING - OSTEOS..., manufactured by Azary Technologies, LLC. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K013672 · Azary Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
153d
Days
Class 2
Risk

K013672 is an FDA 510(k) clearance for the BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Azary Technologies, LLC (Huntington, US). The FDA issued a Cleared decision on April 8, 2002 after a review of 153 days - an extended review 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: 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 Azary Technologies, LLC devices

FDA 510(k) Submission Details - K013672

510(k) Number K013672 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2001
Decision Date April 08, 2002
Days to Decision 153 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
26d slower than avg
Panel avg: 127d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

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 248
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K013672.
THE BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY
K021684 · Bioplate, Inc. · Jun 2002
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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
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
K014263 · Stryker Instruments · Mar 2002
BIOSORBFX O/M 2.0/2/4 SYSTEM
K011569 · Bionx Implants, Inc. · Feb 2002