Cleared Traditional

K034027 - KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM

K034027 is an FDA 510(k) clearance for KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM, manufactured by KLS-Martin L.P.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K034027 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2004
Decision
60d
Days
Class 2
Risk

K034027 is an FDA 510(k) clearance for the KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 27, 2004 after a review of 60 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all KLS-Martin L.P. devices

FDA 510(k) Submission Details - K034027

510(k) Number K034027 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2003
Decision Date February 27, 2004
Days to Decision 60 days
Submission Type Traditional
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
67d faster than avg
Panel avg: 127d · This submission: 60d
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 51
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K034027.
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
K042278 · Oral Osteodistraction, L.P. · Jan 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169 · Synthes (Usa) · Apr 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · Synthes (Usa) · Mar 2004
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
K031708 · Osteomed LP · Nov 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · KLS-Martin L.P. · Oct 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · Synthes (Usa) · Oct 2003