Cleared Traditional

K063386 - LORENZ ORTHODONTIC ANCHORAGE SYSTEM (FDA 510(k) Clearance)

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

K063386 · Walter Lorenz Surgical, Inc. · Dental device
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Feb 2007
Decision
93d
Days
Class 2
Risk

K063386 is an FDA 510(k) clearance for the LORENZ ORTHODONTIC ANCHORAGE SYSTEM. Classified as Implant, Endosseous, Orthodontic (product code OAT), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on February 9, 2007 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - 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 K063386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2006
Decision Date February 09, 2007
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OAT Implant, Endosseous, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
Definition It Is Intended To Provide A Fixed Anchorage Point For Attachment Of Orthodontic Appliances To Facilitate The Orthodontic Movement Of Teeth. It Is Used Temporarily And Is Removed After Orthodontic Treatment Has Been Completed.
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.