Class Class II

MEM Clear Aligner System (K242637)

K242637 2025-05-21 Traditional
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Description

MEM Clear Aligner System by Mem Dental Technology Co., Ltd., an FDA 510(k) cleared dental device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK242637
Clearance Date2025-05-21
Clearance TypeTraditional
Product CodeNXC
Regulation Number872.5470

Categories

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Predicate lineage for K242637

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. MEM Clear Aligner System (K242637) 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
K192596ULab Systems Dental Aligner KitUlab Systems, Inc.2020

Trace the full predicate network for K242637

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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