DENTALOS PLUS 单色, DENTALOS PLUS 多色
K号: K152215 · 2016-01-19
广告
决定日期2016-01-19
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
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR is the device name listed in this FDA 510(k) record. The listed applicant is Dentalplus GmbH. It received FDA 510(k) clearance on 2016-01-19 under 510(k) number K152215. 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 DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR?
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR is a medical device that received FDA 510(k) clearance on 2016-01-19. The listed applicant is Dentalplus GmbH. The 510(k) number is K152215.
When did DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR receive FDA 510(k) clearance?
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR received FDA 510(k) clearance on 2016-01-19, under 510(k) number K152215.
Who is the listed applicant for DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR?
The FDA 510(k) record lists Dentalplus GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR?
The FDA product code for DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR 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。
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