Cleared Traditional

K993869 - INTER-OS BONE GENERATOR

K993869 is an FDA 510(k) clearance for INTER-OS BONE GENERATOR, manufactured by Inter-Os Technologies, LLC. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K993869 · Inter-Os Technologies, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2000
Decision
65d
Days
Class 2
Risk

K993869 is an FDA 510(k) clearance for the INTER-OS BONE GENERATOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Inter-Os Technologies, LLC (Aurora, US). The FDA issued a Cleared decision on January 19, 2000 after a review of 65 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 Inter-Os Technologies, LLC devices

FDA 510(k) Submission Details - K993869

510(k) Number K993869 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date January 19, 2000
Days to Decision 65 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
62d faster than avg
Panel avg: 127d · This submission: 65d
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 K993869.
TRACK 1.0 & 1.5 MM SYSTEMS-TISSUE REGENERATION BY ALVEOLAR CALLUS DISTRACTION
K002152 · KLS-Martin L.P. · Oct 2000
ZURICH PEDIATRIC MAXILLARY DISTRACTOR, MODELS 51-550-15 AND 51-551-15
K000580 · KLS-Martin L.P. · Jul 2000
MACROPOREDX DISTRACTOR SYSTEM
K000992 · Macropore Biosurgery, Inc. · Jun 2000
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