Cleared Traditional

K030790 - OSTEOMED ALVEOLAR DISTRACTION SYSTEM

K030790 is an FDA 510(k) clearance for OSTEOMED ALVEOLAR DISTRACTION SYSTEM, manufactured by Osteomed LP. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K030790 · Osteomed LP · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
182d
Days
Class 2
Risk

K030790 is an FDA 510(k) clearance for the OSTEOMED ALVEOLAR DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Osteomed LP (Addison, US). The FDA issued a Cleared decision on September 10, 2003 after a review of 182 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 Osteomed LP devices

FDA 510(k) Submission Details - K030790

510(k) Number K030790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2003
Decision Date September 10, 2003
Days to Decision 182 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
55d slower than avg
Panel avg: 127d · This submission: 182d
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 56
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K030790.
OSTEOMED MAXILLARY/LEFORT III DISTRACTION SYSTEM
K031708 · Osteomed LP · Nov 2003
KLS-MARTIN MANDIBULAR/RECONSTRUCTION SYSTEM II
K032442 · KLS-Martin L.P. · Oct 2003
SYNTHES 2.0 MM CRANIOFACIAL LOCKING PLATES
K033065 · Synthes (Usa) · Oct 2003
LORENZE EXTERNAL MANDIBULAR DISTRACTOR
K031696 · Walter Lorenz Surgical, Inc. · Jun 2003
INTRAORAL MANDIBULAR DISTRACTION SYSTEM
K013618 · Osteomed Corp. · Aug 2002
LORENZ BLUE DEVICE
K020407 · Walter Lorenz Surgical, Inc. · Feb 2002