Cleared Abbreviated

K042345 - LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (FDA 510(k) Clearance)

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K042345 · Mondeal Medical Systems GmbH · Dental device
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Jan 2005
Decision
136d
Days
Class 2
Risk

K042345 is an FDA 510(k) clearance for the LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mondeal Medical Systems GmbH (Amsterdam, NL). The FDA issued a Cleared decision on January 13, 2005 after a review of 136 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Mondeal Medical Systems GmbH devices

Submission Details

510(k) Number K042345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date January 13, 2005
Days to Decision 136 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 127d · This submission: 136d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
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 - DZE Implant, Endosseous, Root-form

All 1541
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