DENTCA 冠桥
K号: K192806 · 2020-02-05
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申请人Dentca, Inc.
决定日期2020-02-05
产品代码EBG
咨询委员会DE
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决定实质等同
器械摘要
DENTCA Crown and Bridge is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2020-02-05 under 510(k) number K192806. 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 DENTCA Crown and Bridge?
DENTCA Crown and Bridge is a medical device that received FDA 510(k) clearance on 2020-02-05. The listed applicant is Dentca, Inc.. The 510(k) number is K192806.
When did DENTCA Crown and Bridge receive FDA 510(k) clearance?
DENTCA Crown and Bridge received FDA 510(k) clearance on 2020-02-05, under 510(k) number K192806.
Who is the listed applicant for DENTCA Crown and Bridge?
The FDA 510(k) record lists Dentca, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DENTCA Crown and Bridge?
The FDA product code for DENTCA Crown and Bridge 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Dentca, Inc.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。
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