FDA 510(k)

LunaGuard Nighttime Dental Protector

Número K: K191033 · 2019-08-05

Data da decisão2019-08-05

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

LunaGuard Nighttime Dental Protector is the device name listed in this FDA 510(k) record. The listed applicant is Mckeon Products. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K191033. 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 LunaGuard Nighttime Dental Protector?

LunaGuard Nighttime Dental Protector is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Mckeon Products. The 510(k) number is K191033.

When did LunaGuard Nighttime Dental Protector receive FDA 510(k) clearance?

LunaGuard Nighttime Dental Protector received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191033.

Who is the listed applicant for LunaGuard Nighttime Dental Protector?

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

What is the FDA product code for LunaGuard Nighttime Dental Protector?

The FDA product code for LunaGuard Nighttime Dental Protector is OBR. This falls under the Orthopedic category.

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