Cleared Special

K050257 - LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE)

K050257 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 Special 510(k) pathway after a 4-day FDA review.

K050257 · Mondeal Medical Systems GmbH · Dental device
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Feb 2005
Decision
4d
Days
Class 2
Risk

K050257 is an FDA 510(k) clearance for the LIN/LIOU ORTHODONTIC MINI ANCHOR SYSTEM (LOMAS) (STERILE). 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 February 7, 2005 after a review of 4 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Mondeal Medical Systems GmbH devices

FDA 510(k) Submission Details - K050257

510(k) Number K050257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2005
Decision Date February 07, 2005
Days to Decision 4 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 127d · This submission: 4d
Pathway characteristics
Modification to existing cleared device.

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 952
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