FDA 510(k)

Clear Aligner (SCF-3348)

Número K: K251454 · 2026-01-07

RequerenteBeame Medical Technology (Shenzhen) Limited

Data da decisão2026-01-07

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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