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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 a medical device manufactured by Beame Medical Technology (Shenzhen) Limited. It received FDA 510(k) clearance on 2026-01-07 under approval 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. It is manufactured by Beame Medical Technology (Shenzhen) Limited. The 510(k) number is K251454.

When was Clear Aligner (SCF-3348) approved by the FDA?

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

What company makes Clear Aligner (SCF-3348)?

Clear Aligner (SCF-3348) is manufactured by Beame Medical Technology (Shenzhen) Limited.

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

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

Related Clinical Trials

NCT07610603 Cleaning Methods for Clear Aligners COMPLETED NCT07608302 Comparison of the Predictability of Dentoalveolar Expansion With Two Clear Aligner Systems COMPLETED NCT07591025 Comparison Between Mandibular Advancement With Aligners and Twin Block in Class II Malocclusion in Growing Patients COMPLETED NCT07586163 Effectiveness of Clear Aligner Systems in Mixed Dentition Maxillary Transverse Deficiency ACTIVE_NOT_RECRUITING NCT07533058 Influence of Finishing Clear Aligner Marginal Termination Design on Subgingival Periodontal Microbiota During Orthodontic Treatment: A Split-Mouth Study. RECRUITING NCT07420777 Investigate the Effectiveness of 3D-printed Shape Memory Aligners in the Treatment of Anterior Open Bite RECRUITING

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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.

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