FDA 510(k)

Guarda Antigrind

N.º K: K240810 · 2024-05-24

SolicitanteXiamen Yizhou Imp. & Exp. Co., Ltd.

Fecha de decisión2024-05-24

Código de productoOBR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Anti Grinding Guard is the device name listed in this FDA 510(k) record. The listed applicant is Xiamen Yizhou Imp. & Exp. Co., Ltd.. It received FDA 510(k) clearance on 2024-05-24 under 510(k) number K240810. 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.

Preguntas frecuentes

What is the Anti Grinding Guard?

Anti Grinding Guard is a medical device that received FDA 510(k) clearance on 2024-05-24. The listed applicant is Xiamen Yizhou Imp. & Exp. Co., Ltd.. The 510(k) number is K240810.

When did Anti Grinding Guard receive FDA 510(k) clearance?

Anti Grinding Guard received FDA 510(k) clearance on 2024-05-24, under 510(k) number K240810.

Who is the listed applicant for Anti Grinding Guard?

The FDA 510(k) record lists Xiamen Yizhou Imp. & Exp. Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Anti Grinding Guard?

The FDA product code for Anti Grinding Guard is OBR. This falls under the Orthopedic category.

Ensayos clínicos relacionados

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Dispositivos relacionados (Código: 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

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.