Cleared Traditional

K955640 - LORENZ MANDIBULAR DISTRACTOR

K955640 is an FDA 510(k) clearance for LORENZ MANDIBULAR DISTRACTOR, manufactured by Biomet, Inc.. The device is a Class 2 Dental device with product code MQN cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K955640 · Biomet, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
64d
Days
Class 2
Risk

K955640 is an FDA 510(k) clearance for the LORENZ MANDIBULAR DISTRACTOR. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Biomet, Inc. (Warsaw, US). The FDA issued a Cleared decision on February 14, 1996 after a review of 64 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 Biomet, Inc. devices

FDA 510(k) Submission Details - K955640

510(k) Number K955640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1995
Decision Date February 14, 1996
Days to Decision 64 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
63d faster than avg
Panel avg: 127d · This submission: 64d
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 K955640.
KLS-MARTIN RIGID EXTERNAL DISTRACTION DEVICE
K972047 · KLS-Martin L.P. · Jun 1997
SYNTHES MANDIBLE DISTRACTOR
K962272 · Synthes (Usa) · Aug 1996
MANDIBULAR BONE DISTRACTOR II
K960297 · Howmedica Corp. · Aug 1996
NORMED BIDIRECTRIONAL/MULTIDIRECTIONAL JAW DISTRACTOR
K952847 · Ace Surgical Supply Co., Inc. · Feb 1996
MANDIBULAR BONE DISTRACTOR
K945674 · Howmedica Corp. · Jun 1995