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FDA 510(k)

MEM Clear Aligner System

K-Number: K242637 · 2025-05-21

Decision Date2025-05-21
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEM Clear Aligner System is a medical device manufactured by Mem Dental Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-05-21 under approval number K242637. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEM Clear Aligner System?

MEM Clear Aligner System is a medical device that received FDA 510(k) clearance on 2025-05-21. It is manufactured by Mem Dental Technology Co., Ltd.. The 510(k) number is K242637.

When was MEM Clear Aligner System approved by the FDA?

MEM Clear Aligner System received FDA 510(k) clearance on 2025-05-21, under approval number K242637.

What company makes MEM Clear Aligner System?

MEM Clear Aligner System is manufactured by Mem Dental Technology Co., Ltd..

What is the FDA product code for MEM Clear Aligner System?

The FDA product code for MEM Clear Aligner System is NXC.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.