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510(k) Data Aggregation
K Number
K242637Device Name
MEM Clear Aligner System
Manufacturer
MEM Dental Technology Co., Ltd.
Date Cleared
2025-05-21
(260 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
MEM Dental Technology Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MEM Clear Aligner System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The MEM Clear Aligner System repositions teeth by way of continuous gentle force.
Device Description
The MEM Clear Aligner System is a customized plastic orthodontic system, consisting of a series of transparent, removable aligners prescribed by a doctor to correct misaligned or crooked teeth. These customized, removable transparent plastic aligners gradually reposition teeth with continuous gentle pressure.
The product is a series of transparent, removable orthodontic aligners, custom-made according to the dentist's prescription and designed using the "3Shape A/S (K171634)" software. They are manufactured using thermoforming technology. These aligners are designed to provide a comfortable teeth straightening experience and achieve optimal correction through precise design using advanced technology.
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