Cleared Traditional

K990944 - OSTEOMED INTRAORAL DISTRACTION SYSTEM

K990944 is the FDA 510(k) clearance for OSTEOMED INTRAORAL DISTRACTION SYSTEM by Osteomed Corp.. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K990944 · Osteomed Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1999
Decision
86d
Days
Class 2
Risk

K990944 is an FDA 510(k) clearance for the OSTEOMED INTRAORAL DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Osteomed Corp. (Addison, US). The FDA issued a Cleared decision on June 16, 1999 after a review of 86 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 Osteomed Corp. devices

Submission Details

510(k) Number K990944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 1999
Decision Date June 16, 1999
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
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 45
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K990944.
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 MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
K983809 · KLS-Martin L.P. · Jan 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