Anti Grinding Guard
K-Number: K240810 · 2024-05-24
ApplicantXiamen Yizhou Imp. & Exp. Co., Ltd.
Decision Date2024-05-24
Product CodeOBR
DecisionSubstantially Equivalent
Device Summary
Anti Grinding Guard is a medical device manufactured by Xiamen Yizhou Imp. & Exp. Co., Ltd.. It received FDA 510(k) clearance on 2024-05-24 under approval 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.
Frequently Asked Questions
What is the Anti Grinding Guard?
Anti Grinding Guard is a medical device that received FDA 510(k) clearance on 2024-05-24. It is manufactured by Xiamen Yizhou Imp. & Exp. Co., Ltd.. The 510(k) number is K240810.
When was Anti Grinding Guard approved by the FDA?
Anti Grinding Guard received FDA 510(k) clearance on 2024-05-24, under approval number K240810.
What company makes Anti Grinding Guard?
Anti Grinding Guard is manufactured by Xiamen Yizhou Imp. & Exp. Co., Ltd..
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.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.