恩科尔夜牙套
K号: K252004 · 2025-11-25
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器械摘要
enCore Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Encore Guards. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K252004. 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 enCore Night Guard?
enCore Night Guard is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Encore Guards. The 510(k) number is K252004.
When did enCore Night Guard receive FDA 510(k) clearance?
enCore Night Guard received FDA 510(k) clearance on 2025-11-25, under 510(k) number K252004.
Who is the listed applicant for enCore Night Guard?
The FDA 510(k) record lists Encore Guards as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for enCore Night Guard?
The FDA product code for enCore 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。
列明Encore Guards为申报人的其他记录
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。
K262559口腔保护器ChangSha ChuangDuoLe E-Commerce Co., Ltd.K260790G系列磨削保护器ASESSO HEALTH, Inc.K252485ClenchNoMore (CNM-1 (混合尺寸)); ClenchNoMore (CNM-L (大尺寸)); ClenchNoMore (CNM-S (小尺寸))1987 Media LimitedK253641Owl 夜间护牙器Owl Dental Lab, Inc.K251778Remi定制夜间牙套RemiK250456Dentemp Pro-Comfort Dental GuardDoc Brands, Inc.
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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