Cleared Traditional

K002083 - LORENZ RESORBABLE DISTRACTOR SYSTEM (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K002083 · Walter Lorenz Surgical, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2001
Decision
217d
Days
Class 2
Risk

K002083 is an FDA 510(k) clearance for the LORENZ RESORBABLE DISTRACTOR SYSTEM. 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 February 12, 2001 after a review of 217 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 Walter Lorenz Surgical, Inc. devices

Submission Details

510(k) Number K002083 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date February 12, 2001
Days to Decision 217 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 127d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 291
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K002083.
Leforte MMF System
K252246 · Jeil Medical Corporation · Apr 2026
Southern Craniomaxillofacial (CMF) System
K253373 · Southern Medical (Pty) , Ltd. · Dec 2025
Inion CPS 1.5 Baby Bioabsorbable Fixation System
K251441 · Inion OY · Nov 2025
KLS Martin Oral-Max Implants MR Conditional (bundled)
K241314 · KLS-Martin L.P. · Aug 2024
MRI Universal
K240651 · Stryker Leibinger GmbH & Co KG · Jul 2024
tmCMF Solution
K233874 · Techmah Cmf · Jul 2024