Cleared Abbreviated

K042345 - LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)

K042345 is an FDA 510(k) clearance for LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM..., manufactured by Mondeal Medical Systems GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 136-day FDA review.

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.

FDA 510(k) Submission Details - K042345

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 128d · This submission: 136d
Pathway characteristics
Standards-based clearance path.

DZE Device Classification - Class 2, Special Controls

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 1529
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K042345.
NEO IMPLANT SYSTEM
K043195 · Neoss, Ltd. · Mar 2005
LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)
K050257 · Mondeal Medical Systems GmbH · Feb 2005
TITAN DENTAL IMPLANT SYSTEM
K042971 · Titan Implants, Inc. · Jan 2005
ENDURE IMPLANT, MODELS 3508, 4308, 3520, 4320
K043226 · Imtec Corp. · Jan 2005
BICONITE SURFACE TREATMENT
K031568 · Bicon, Inc. · Nov 2004
THE 5.0 X 6.0MM DENTAL IMPLANT
K042637 · Bicon, Inc. · Nov 2004
K042345 · LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS)
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