FDA 510(k)

Ohlendorf Clear Aligner

N.º K: K210540 · 2021-05-19

SolicitanteOhlendorf Appliance Laboratory

Fecha de decisión2021-05-19

Código de productoNXC

Comité asesorDE

DecisiónSubstantially Equivalent

Resumen del dispositivo

Ohlendorf Clear Aligner is the device name listed in this FDA 510(k) record. The listed applicant is Ohlendorf Appliance Laboratory. It received FDA 510(k) clearance on 2021-05-19 under 510(k) number K210540. The device is classified under product code NXC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Ohlendorf Clear Aligner?

Ohlendorf Clear Aligner is a medical device that received FDA 510(k) clearance on 2021-05-19. The listed applicant is Ohlendorf Appliance Laboratory. The 510(k) number is K210540.

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

Ohlendorf Clear Aligner received FDA 510(k) clearance on 2021-05-19, under 510(k) number K210540.

Who is the listed applicant for Ohlendorf Clear Aligner?

The FDA 510(k) record lists Ohlendorf Appliance Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ohlendorf Clear Aligner?

The FDA product code for Ohlendorf Clear Aligner is NXC.

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Fuente oficial

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