FDA 510(k)

FBCC Night Guard

Número K: K221369 · 2022-11-18

Data da decisão2022-11-18

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

FBCC Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Fbcc, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) number K221369. 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 FBCC Night Guard?

FBCC Night Guard is a medical device that received FDA 510(k) clearance on 2022-11-18. The listed applicant is Fbcc, Inc.. The 510(k) number is K221369.

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

FBCC Night Guard received FDA 510(k) clearance on 2022-11-18, under 510(k) number K221369.

Who is the listed applicant for FBCC Night Guard?

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

What is the FDA product code for FBCC Night Guard?

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

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