Cleared Traditional

K983809 - KLS MARTIN INTRAORAL ZURICH RAMUS DISTR...

K983809 is the FDA 510(k) clearance for KLS MARTIN INTRAORAL ZURICH RAMUS DISTR... by KLS-Martin L.P.. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K983809 · KLS-Martin L.P. · Dental device
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Jan 1999
Decision
90d
Days
Class 2
Risk

K983809 is an FDA 510(k) clearance for the KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR. 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 January 26, 1999 after a review of 90 days - within the typical 510(k) review window.

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 KLS-Martin L.P. devices

Submission Details

510(k) Number K983809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1998
Decision Date January 26, 1999
Days to Decision 90 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
37d faster than avg
Panel avg: 127d · This submission: 90d
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 K983809.
LORENZ DISTRACTION SYSTEM
K992952 · Walter Lorenz Surgical, Inc. · Nov 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · Walter Lorenz Surgical, Inc. · Sep 1999
K-L-W INTRAORAL DISTRACTOR
K991875 · KLS-Martin L.P. · Aug 1999
KLS INTRAORAL VERTICAL DISTRACTOR
K983515 · KLS-Martin L.P. · Nov 1998
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
K982906 · Walter Lorenz Surgical, Inc. · Nov 1998
LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM
K982604 · Walter Lorenz Surgical, Inc. · Oct 1998