Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MEM Clear Aligner System

K-Number: K242637 · 2025-05-21

ApplicantMem Dental Technology Co., Ltd.
Decision Date2025-05-21
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

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.

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. 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.

Other records listing Mem Dental Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180952Ceramic Bracket

Related Devices (Code: NXC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260527FACE4D AlignerAvinent Implant System S.L.U.K260788Smylio AlignersSmylio, Inc.K260722SureSmile Aligner (ASSY500020)Dentsply Sirona, Inc.K253282ZSmile SystemDror Orthodesign , Ltd.K251454Clear Aligner (SCF-3348)Beame Medical Technology (Shenzhen) LimitedK250739Primeprint Direct AlignerDreve Dentamid GmbH

Official Source

View on FDA Database →

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

↑