Cleared Traditional

K922741 - LORENZ 1.0 MM SYSTEM (FDA 510(k) Clearance)

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

K922741 · Walter Lorenz Surgical, Inc. · Dental device
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Dec 1992
Decision
198d
Days
Class 2
Risk

K922741 is an FDA 510(k) clearance for the LORENZ 1.0 MM 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 December 23, 1992 after a review of 198 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 K922741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1992
Decision Date December 23, 1992
Days to Decision 198 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 127d · This submission: 198d
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.

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