FDA 510(k)

Remi Custom Night Guard

Número K: K251778 · 2025-10-17

RequerenteRemi

Data da decisão2025-10-17

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

Remi Custom Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Remi. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251778. 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.

Perguntas frequentes

What is the Remi Custom Night Guard?

Remi Custom Night Guard is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Remi. The 510(k) number is K251778.

When did Remi Custom Night Guard receive FDA 510(k) clearance?

Remi Custom Night Guard received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251778.

Who is the listed applicant for Remi Custom Night Guard?

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

What is the FDA product code for Remi Custom Night Guard?

The FDA product code for Remi Custom Night Guard is OBR. This falls under the Orthopedic category.

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Fonte oficial

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