Class Class II

USTOMED Bone Fixation/Bone Augmentation Systems – PIN (K243190)

K243190 2025-06-27 Traditional
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Description

USTOMED Bone Fixation/Bone Augmentation Systems - PIN by Ustomed Instrumente Ulrich Storz GmbH & Co. KG, an FDA 510(k) cleared dental device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243190
Clearance Date2025-06-27
Clearance TypeTraditional
Product CodeDZL
Regulation Number872.4880

Categories

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Predicate lineage for K243190

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. USTOMED Bone Fixation/Bone Augmentation Systems – PIN (K243190) cites 1 predicate device and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K201561Membrane Screws and Membrane TacksNeoss Limited2020

Trace the full predicate network for K243190

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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