FDA 510(k)

MEM Clear正畸系统

K号: K242637 · 2025-05-21

决定日期2025-05-21

产品代码NXC

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决定实质等同

器械摘要

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

常见问题

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. The listed applicant is Mem Dental Technology Co., Ltd.. The 510(k) number is K242637.

When did MEM Clear Aligner System receive FDA 510(k) clearance?

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

Who is the listed applicant for MEM Clear Aligner System?

The FDA 510(k) record lists Mem Dental Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

列明Mem Dental Technology Co., Ltd.为申报人的其他记录

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