Remi定制夜间牙套
K号: K251778 · 2025-10-17
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器械摘要
Remi Custom Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Remi. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K251778. 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.
常见问题
What is the Remi Custom Night Guard?
Remi Custom Night Guard is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Remi. The 510(k) number is K251778.
When did Remi Custom Night Guard receive FDA 510(k) clearance?
Remi Custom Night Guard received FDA 510(k) clearance on 2025-10-17, under 510(k) number K251778.
Who is the listed applicant for Remi Custom Night Guard?
The FDA 510(k) record lists Remi as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Remi Custom Night Guard?
The FDA product code for Remi Custom Night Guard is OBR. This falls under the Orthopedic category.
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
相关器械（代码：OBR）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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