FDA 510(k)

LunaGuard Nighttime Dental Protector

Номер K: K191033 · 2019-08-05

Дата решения2019-08-05

Код продуктаOBR

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: OBR)

K262559Mouth GuardChangSha ChuangDuoLe E-Commerce Co., Ltd.K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media Limited K253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore Guards K251778Remi Custom Night GuardRemi

Официальный источник

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