FDA 510(k)

Pearl Clear Aligner

Número K: K242715 · 2025-01-16

Data da decisão2025-01-16

Código do produtoNXC

Comité consultivoDE

DecisãoSubstantially Equivalent

Resumo do dispositivo

Pearl Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Pearl Digital, Inc.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K242715. 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 Pearl Clear Aligner?

Pearl Clear Aligner is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Pearl Digital, Inc.. The 510(k) number is K242715.

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

Pearl Clear Aligner received FDA 510(k) clearance on 2025-01-16, under 510(k) number K242715.

Who is the listed applicant for Pearl Clear Aligner?

The FDA 510(k) record lists Pearl Digital, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pearl Clear Aligner?

The FDA product code for Pearl Clear Aligner is NXC.

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Fonte oficial

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