Cleared Traditional

K991875 - K-L-W INTRAORAL DISTRACTOR

K991875 is an FDA 510(k) clearance for K-L-W INTRAORAL DISTRACTOR, 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 77-day FDA review.

K991875 · KLS-Martin L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
77d
Days
Class 2
Risk

K991875 is an FDA 510(k) clearance for the K-L-W INTRAORAL 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 August 18, 1999 after a review of 77 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 - K991875

510(k) Number K991875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 1999
Decision Date August 18, 1999
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K991875.
INTER-OS BONE GENERATOR
K993869 · Inter-Os Technologies, LLC · Jan 2000
LORENZ DISTRACTION SYSTEM
K992952 · Walter Lorenz Surgical, Inc. · Nov 1999
LORENZ EXTERNAL MANDIBULAR DISTRACTOR
K992873 · Walter Lorenz Surgical, Inc. · Sep 1999
OSTEOMED INTRAORAL DISTRACTION SYSTEM
K990944 · Osteomed Corp. · Jun 1999
INNOVA TELESCOPIC DISTRACTOR
K984117 · Innova Corp. · Feb 1999
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
K983809 · KLS-Martin L.P. · Jan 1999