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FDA 510(k)

Mouth Guard (ATG0603R)

N.º K: K231865 · 2023-11-06

SolicitanteReazeal Corp
Fecha de decisión2023-11-06
Código de productoOBR
DecisiónSubstantially Equivalent

Resumen del dispositivo

Mouth Guard (ATG0603R) is the device name listed in this FDA 510(k) record. The listed applicant is Reazeal Corp. It received FDA 510(k) clearance on 2023-11-06 under 510(k) number K231865. The device is classified under product code OBR. Product code OBR falls under the category of Orthopedic, which includes orthopedic implants, fixation devices, and surgical instruments. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Mouth Guard (ATG0603R)?

Mouth Guard (ATG0603R) is a medical device that received FDA 510(k) clearance on 2023-11-06. The listed applicant is Reazeal Corp. The 510(k) number is K231865.

When did Mouth Guard (ATG0603R) receive FDA 510(k) clearance?

Mouth Guard (ATG0603R) received FDA 510(k) clearance on 2023-11-06, under 510(k) number K231865.

Who is the listed applicant for Mouth Guard (ATG0603R)?

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

What is the FDA product code for Mouth Guard (ATG0603R)?

The FDA product code for Mouth Guard (ATG0603R) is OBR. This falls under the Orthopedic category.

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Dispositivos relacionados (Código: OBR)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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