Cleared Traditional

K002152 - TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGEN...

K002152 is the FDA 510(k) clearance for TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGEN... by KLS-Martin L.P.. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K002152 · KLS-Martin L.P. · Dental device
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Oct 2000
Decision
85d
Days
Class 2
Risk

K002152 is an FDA 510(k) clearance for the TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by KLS-Martin L.P. (New Port Riche, US). The FDA issued a Cleared decision on October 10, 2000 after a review of 85 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

Submission Details

510(k) Number K002152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2000
Decision Date October 10, 2000
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K002152.
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696 · Walter Lorenz Surgical, Inc. · Jun 2003
LORENZ BLUE DEVICE
K020407 · Walter Lorenz Surgical, Inc. · Feb 2002
ZURICH DISTRACTION SYSTEM
K010139 · KLS-Martin L.P. · Jun 2001
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
K000580 · KLS-Martin L.P. · Jul 2000
LORENZ DISTRACTION SYSTEM
K992952 · Walter Lorenz Surgical, Inc. · Nov 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · Walter Lorenz Surgical, Inc. · Sep 1999