Cleared Traditional

BRUGES DISTRACTION - ANCHORING - OSTEOSYNTHESIS SYSTEM (K013672) - FDA 510(k) Clearance

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

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

Submission Details

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.

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 90
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K013672.
SYNTHES CRANIOFACIAL PLATES
K021642 · Synthes (Usa) · Aug 2002
SYNTHES (USA) AUTOMATED TACK DRIVER
K021382 · Synthes (Usa) · May 2002
SYNTHES TRANSLATING MAXILLARY DISTRACTOR
K020505 · Synthes (Usa) · Apr 2002
SYNTHES CRANIAL PLATES
K020087 · Synthes (Usa) · Feb 2002
LACTOSORB RAPIDFLAP
K003281 · Biomet, Inc. · Aug 2001
SYNTHES (USA) MIDFACE DISTRACTOR
K010499 · Synthes (Usa) · May 2001