TurboTemp EZ
K号: K191619 · 2019-09-11
广告
决定日期2019-09-11
产品代码EBG
咨询委员会DE
请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同
器械摘要
TurboTemp EZ is the device name listed in this FDA 510(k) record. The listed applicant is Zest Anchors, LLC. It received FDA 510(k) clearance on 2019-09-11 under 510(k) number K191619. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TurboTemp EZ?
TurboTemp EZ is a medical device that received FDA 510(k) clearance on 2019-09-11. The listed applicant is Zest Anchors, LLC. The 510(k) number is K191619.
When did TurboTemp EZ receive FDA 510(k) clearance?
TurboTemp EZ received FDA 510(k) clearance on 2019-09-11, under 510(k) number K191619.
Who is the listed applicant for TurboTemp EZ?
The FDA 510(k) record lists Zest Anchors, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TurboTemp EZ?
The FDA product code for TurboTemp EZ is EBG.
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Zest Anchors, LLC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：EBG）
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。
K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT 基础”和“FLNT 临时”Liaoning Upcera Co., Ltd.K251271TempFIT 临时牙冠和牙桥树脂Rizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA基牙科树脂Taiwan Dental Materials Co., Ltd.
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。
广告