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)

Clear Aligner (SCF-3348)

K-Number: K251454 · 2026-01-07

ApplicantBeame Medical Technology (Shenzhen) Limited
Decision Date2026-01-07
Product CodeNXC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Clear Aligner (SCF-3348) is the device name listed in this FDA 510(k) record. The listed applicant is Beame Medical Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-01-07 under 510(k) number K251454. 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 Clear Aligner (SCF-3348)?

Clear Aligner (SCF-3348) is a medical device that received FDA 510(k) clearance on 2026-01-07. The listed applicant is Beame Medical Technology (Shenzhen) Limited. The 510(k) number is K251454.

When did Clear Aligner (SCF-3348) receive FDA 510(k) clearance?

Clear Aligner (SCF-3348) received FDA 510(k) clearance on 2026-01-07, under 510(k) number K251454.

Who is the listed applicant for Clear Aligner (SCF-3348)?

The FDA 510(k) record lists Beame Medical Technology (Shenzhen) Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Clear Aligner (SCF-3348)?

The FDA product code for Clear Aligner (SCF-3348) is NXC.

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.K250739Primeprint Direct AlignerDreve Dentamid GmbHK252931Invisalign® Palatal Expander SystemAlign Technology, Inc.

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.

↑