Cleared Traditional

K982604 - LORENZ MAXILLA (LE FORT) DISTRACTION SY...

K982604 is the FDA 510(k) clearance for LORENZ MAXILLA (LE FORT) DISTRACTION SY... by Walter Lorenz Surgical, Inc.. It is a Class 2 Dental device (product code MQN) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K982604 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
88d
Days
Class 2
Risk

K982604 is an FDA 510(k) clearance for the LORENZ MAXILLA (LE FORT) DISTRACTION SYSTEM. Classified as External Mandibular Fixator And/or Distractor (product code MQN), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 23, 1998 after a review of 88 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 Walter Lorenz Surgical, Inc. devices

Submission Details

510(k) Number K982604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1998
Decision Date October 23, 1998
Days to Decision 88 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
39d faster than avg
Panel avg: 127d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 38
Devices cleared under the same product code (MQN) and FDA review panel - the closest regulatory comparables to K982604.
KLS MARTIN INTRAORAL ZURICH RAMUS DISTRACTOR
K983809 · KLS-Martin L.P. · Jan 1999
KLS INTRAORAL VERTICAL DISTRACTOR
K983515 · KLS-Martin L.P. · Nov 1998
LORENZ INTRAORAL LINEAR MANDIBULAR DISTRACTION SYSTEM
K982906 · Walter Lorenz Surgical, Inc. · Nov 1998
SYNTHES (USA) RATCHETING DISTRACTOR
K981275 · Synthes (Usa) · Jun 1998
SYNTHES (USA) (SYNTHES) SINGLE VECTOR DISTRACTOR WITH DETACHABLE FEET
K981075 · Synthes (Usa) · Jun 1998
KLS-MARTIN INTRAORAL DISTRACTOR
K973275 · KLS-Martin L.P. · Nov 1997