Cleared Traditional

K030425 - LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER

K030425 is an FDA 510(k) clearance for LORENZ RESORBABLE DISTRACTION SYSTEM OR..., manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 459-day FDA review.

K030425 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2004
Decision
459d
Days
Class 2
Risk

K030425 is an FDA 510(k) clearance for the LORENZ RESORBABLE DISTRACTION SYSTEM OR EXPANDER. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on May 14, 2004 after a review of 459 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K030425

510(k) Number K030425 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2003
Decision Date May 14, 2004
Days to Decision 459 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
332d slower than avg
Panel avg: 127d · This submission: 459d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
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 - JEY Plate, Bone

All 249
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K030425.
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