Cleared Traditional

K042278 - ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)

K042278 is an FDA 510(k) clearance for ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5), manufactured by Oral Osteodistraction, L.P.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 158-day FDA review.

K042278 · Oral Osteodistraction, L.P. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2005
Decision
158d
Days
Class 2
Risk

K042278 is an FDA 510(k) clearance for the ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5). Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Oral Osteodistraction, L.P. (Appollo Beach, US). The FDA issued a Cleared decision on January 28, 2005 after a review of 158 days - an extended review 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: 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 Oral Osteodistraction, L.P. devices

FDA 510(k) Submission Details - K042278

510(k) Number K042278 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2004
Decision Date January 28, 2005
Days to Decision 158 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
31d slower than avg
Panel avg: 127d · This submission: 158d
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 K042278.
SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR
K043555 · Synthes (Usa) · Apr 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378 · Synthes (Usa) · Mar 2005
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K043434 · Osteomed LP · Feb 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K040169 · Synthes (Usa) · Apr 2004
SYNTHES EXTERNAL MIDFACE DISTRACTOR
K040083 · Synthes (Usa) · Mar 2004
KLS MARTIN 3DX EXTERNAL DISTRACTION SYSTEM
K034027 · KLS-Martin L.P. · Feb 2004