FDA 510(k)

Mouth Guard

Número K: K262559 · 2026-09-16

RequerenteChangSha ChuangDuoLe E-Commerce Co., Ltd.

Data da decisão2026-09-16

Código do produtoOBR

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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