Cleared Traditional

K043555 - SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR

K043555 is an FDA 510(k) clearance for SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR, manufactured by Synthes (Usa). The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K043555 · Synthes (Usa) · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
106d
Days
Class 2
Risk

K043555 is an FDA 510(k) clearance for the SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Synthes (Usa) (Paoli, US). The FDA issued a Cleared decision on April 12, 2005 after a review of 106 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 Synthes (Usa) devices

FDA 510(k) Submission Details - K043555

510(k) Number K043555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2004
Decision Date April 12, 2005
Days to Decision 106 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
21d faster than avg
Panel avg: 127d · This submission: 106d
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 52
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K043555.
SYNTHES STERILE MANDIBLE EXTERNAL FIXATION KIT
K062299 · Synthes (Usa) · Aug 2006
SYNTHES (USA) CRANIOMAXILLOFACIAL DISTRACTION SYSTEM
K060138 · Synthes (Usa) · Jun 2006
MODUS MODULAR DISTRACTION OSTEOGENESIS SYSTEM
K051946 · Medartis, Inc. · Aug 2005
SYNTHES MANDIBLE EXTERNAL FIXATOR
K050378 · Synthes (Usa) · Mar 2005
OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K043434 · Osteomed LP · Feb 2005
ORAL OSTEODISTRACTION ROD APPLIANCE (ROD 5)
K042278 · Oral Osteodistraction, L.P. · Jan 2005