Star E900 电系统
K号: K251701 · 2026-01-12
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决定日期2026-01-12
产品代码EBW
咨询委员会DE
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器械摘要
Star E900 Electric System is the device name listed in this FDA 510(k) record. The listed applicant is Dentalez, Inc., Stardental Division. It received FDA 510(k) clearance on 2026-01-12 under 510(k) number K251701. 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 Star E900 Electric System?
Star E900 Electric System is a medical device that received FDA 510(k) clearance on 2026-01-12. The listed applicant is Dentalez, Inc., Stardental Division. The 510(k) number is K251701.
When did Star E900 Electric System receive FDA 510(k) clearance?
Star E900 Electric System received FDA 510(k) clearance on 2026-01-12, under 510(k) number K251701.
Who is the listed applicant for Star E900 Electric System?
The FDA 510(k) record lists Dentalez, Inc., Stardental Division as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Star E900 Electric System?
The FDA product code for Star E900 Electric System 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Dentalez, Inc., Stardental Division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。
K251407通过塑性诱导皮质刺激进行运动恢复试验Saeshin Precision Co., Ltd.K251811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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