Opus 大块填充 APS，Opus 大块填充 Flow APS
K号: K190758 · 2019-09-04
广告
决定日期2019-09-04
产品代码EBF
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
Opus Bulk Fill APS, Opus Bulk Fill Flow APS is the device name listed in this FDA 510(k) record. The listed applicant is Dentscare Ltda. It received FDA 510(k) clearance on 2019-09-04 under 510(k) number K190758. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Opus Bulk Fill APS, Opus Bulk Fill Flow APS?
Opus Bulk Fill APS, Opus Bulk Fill Flow APS is a medical device that received FDA 510(k) clearance on 2019-09-04. The listed applicant is Dentscare Ltda. The 510(k) number is K190758.
When did Opus Bulk Fill APS, Opus Bulk Fill Flow APS receive FDA 510(k) clearance?
Opus Bulk Fill APS, Opus Bulk Fill Flow APS received FDA 510(k) clearance on 2019-09-04, under 510(k) number K190758.
Who is the listed applicant for Opus Bulk Fill APS, Opus Bulk Fill Flow APS?
The FDA 510(k) record lists Dentscare Ltda as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Opus Bulk Fill APS, Opus Bulk Fill Flow APS?
The FDA product code for Opus Bulk Fill APS, Opus Bulk Fill Flow APS is EBF.
列明Dentscare Ltda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：EBF）
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。
广告