Cleared Traditional

K062572 - CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE

K062572 is an FDA 510(k) clearance for CRANIOTECH BONE TRANSPORT RECONSTRUCTIO..., manufactured by Custom Scientific. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 253-day FDA review.

K062572 · Custom Scientific · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
253d
Days
Class 2
Risk

K062572 is an FDA 510(k) clearance for the CRANIOTECH BONE TRANSPORT RECONSTRUCTION PLATE. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Custom Scientific (Chevy Chase, US). The FDA issued a Cleared decision on May 11, 2007 after a review of 253 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 Custom Scientific devices

FDA 510(k) Submission Details - K062572

510(k) Number K062572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date May 11, 2007
Days to Decision 253 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
126d slower than avg
Panel avg: 127d · This submission: 253d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQN Device Classification - Class 2, Special Controls

Product Code MQN External Mandibular Fixator And/or Distractor
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 - MQN External Mandibular Fixator And/or Distractor

All 50
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K062572.
STRYKER PEDIATRIC MANDIBLE DISTRACTOR
K133398 · Stryker · Mar 2014
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM
K080153 · Synthes (Usa) · May 2008
KLS MARTIN XTERNAL FIXATOR
K072764 · KLS-Martin L.P. · Dec 2007
OSTEOMED EXTERNAL MANDIBULAR DISTRACTION SYSTEM
K063792 · Osteomed LP · Mar 2007
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM, EXTENDED
K062851 · Osteomed LP · Nov 2006
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299 · Synthes (Usa) · Aug 2006