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FDA 510(k)

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 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.

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. 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.

Related Devices (Code: OBR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260790G-Series Grind GuardASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (Mixed sizing)); ClenchNoMore (CNM-L (Large size)); ClenchNoMore (CNM-S (Small size))1987 Media LimitedK253641Owl Night GuardOwl Dental Lab, Inc.K252004enCore Night GuardEncore GuardsK251778Remi Custom Night GuardRemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.

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.

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