Cleared Traditional

K972047 - KLS-MARTIN RIGID EXTERNAL DISTRACTION D...

K972047 is the FDA 510(k) clearance for KLS-MARTIN RIGID EXTERNAL DISTRACTION D... by KLS-Martin L.P.. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K972047 · KLS-Martin L.P. · Dental device
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Jun 1997
Decision
22d
Days
Class 2
Risk

K972047 is an FDA 510(k) clearance for the KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by KLS-Martin L.P. (Tarpon Springs, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 22 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 K972047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1997
Decision Date June 24, 1997
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d faster than avg
Panel avg: 127d · This submission: 22d
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 K972047.
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
K981075 · Synthes (Usa) · Jun 1998
KLS-MARTIN INTRAORAL DISTRACTOR
K973275 · KLS-Martin L.P. · Nov 1997
SYNTHES MINI LENGTHENING APPARATUS
K973018 · Synthes (Usa) · Nov 1997
SYNTHES MANDIBLE DISTRACTOR
K962272 · Synthes (Usa) · Aug 1996
MANDIBULAR BONE DISTRACTOR II
K960297 · Howmedica Corp. · Aug 1996
LORENZ MANDIBULAR DISTRACTOR
K955640 · Biomet, Inc. · Feb 1996