FDA 510(k)

Mouth Guard

Номер K: K262559 · 2026-09-16

ЗаявительChangSha ChuangDuoLe E-Commerce Co., Ltd.

Дата решения2026-09-16

Код продуктаOBR

РешениеSubstantially Equivalent

Описание устройства

Mouth Guard is the device name listed in this FDA 510(k) record. The listed applicant is ChangSha ChuangDuoLe E-Commerce Co., Ltd.. It received FDA 510(k) clearance on 2026-09-16 under 510(k) number K262559. 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 Mouth Guard?

Mouth Guard is a medical device that received FDA 510(k) clearance on 2026-09-16. The listed applicant is ChangSha ChuangDuoLe E-Commerce Co., Ltd.. The 510(k) number is K262559.

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

Mouth Guard received FDA 510(k) clearance on 2026-09-16, under 510(k) number K262559.

Who is the listed applicant for Mouth Guard?

The FDA 510(k) record lists ChangSha ChuangDuoLe E-Commerce Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Mouth Guard?

The FDA product code for Mouth Guard 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)

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 K250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.

Официальный источник

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