Owl 夜间护牙器
K号: K253641 · 2026-02-26
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器械摘要
Owl Night Guard is the device name listed in this FDA 510(k) record. The listed applicant is Owl Dental Lab, Inc.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253641. 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 Owl Night Guard?
Owl Night Guard is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Owl Dental Lab, Inc.. The 510(k) number is K253641.
When did Owl Night Guard receive FDA 510(k) clearance?
Owl Night Guard received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253641.
Who is the listed applicant for Owl Night Guard?
The FDA 510(k) record lists Owl Dental Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Owl Night Guard?
The FDA product code for Owl 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。
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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