通过塑性诱导皮质刺激进行运动恢复试验
K号: K251407 · 2026-01-30
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决定日期2026-01-30
产品代码EBW
咨询委员会DE
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决定实质等同
器械摘要
Motor Handpiece and Control Unit (SDI10) is the device name listed in this FDA 510(k) record. The listed applicant is Saeshin Precision Co., Ltd.. It received FDA 510(k) clearance on 2026-01-30 under 510(k) number K251407. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Motor Handpiece and Control Unit (SDI10)?
Motor Handpiece and Control Unit (SDI10) is a medical device that received FDA 510(k) clearance on 2026-01-30. The listed applicant is Saeshin Precision Co., Ltd.. The 510(k) number is K251407.
When did Motor Handpiece and Control Unit (SDI10) receive FDA 510(k) clearance?
Motor Handpiece and Control Unit (SDI10) received FDA 510(k) clearance on 2026-01-30, under 510(k) number K251407.
Who is the listed applicant for Motor Handpiece and Control Unit (SDI10)?
The FDA 510(k) record lists Saeshin Precision Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Motor Handpiece and Control Unit (SDI10)?
The FDA product code for Motor Handpiece and Control Unit (SDI10) is EBW.
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Saeshin Precision Co., Ltd.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：EBW）
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。
K251701Star E900 电系统Dentalez, Inc., Stardental DivisionK251811运动和顶点模块（MaAM）Dentsply Sirona, Inc.K231562ELEC 发动机（型号：ISE-170L）Micro-Nx Co., Ltd.K242646牙科植入单元Guilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.K233117Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)Nakanishi, 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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