TSV BellaTek Express 和 BellaTek Flex 基台
K号: K192522 · 2019-12-09
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决定日期2019-12-09
产品代码NHA
咨询委员会DE
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决定实质等同
器械摘要
TSV BellaTek Express and BellaTek Flex Abutments is the device name listed in this FDA 510(k) record. The listed applicant is Biomet 3i, LLC. It received FDA 510(k) clearance on 2019-12-09 under 510(k) number K192522. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TSV BellaTek Express and BellaTek Flex Abutments?
TSV BellaTek Express and BellaTek Flex Abutments is a medical device that received FDA 510(k) clearance on 2019-12-09. The listed applicant is Biomet 3i, LLC. The 510(k) number is K192522.
When did TSV BellaTek Express and BellaTek Flex Abutments receive FDA 510(k) clearance?
TSV BellaTek Express and BellaTek Flex Abutments received FDA 510(k) clearance on 2019-12-09, under 510(k) number K192522.
Who is the listed applicant for TSV BellaTek Express and BellaTek Flex Abutments?
The FDA 510(k) record lists Biomet 3i, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TSV BellaTek Express and BellaTek Flex Abutments?
The FDA product code for TSV BellaTek Express and BellaTek Flex Abutments is NHA.
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Biomet 3i, 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：NHA）
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。
K262207水泥固定基台Unidental Co., Ltd.K260940BellaTek BarsZimVie US Corp, LLCK253999通用底座 ASC 启动；通用底座 ASC 非启动；通用底座 MUA ASC；临时基台 启动和非启动；愈合基台 锥形连接；Omnigrip 临床螺丝钛；Omnigrip 假体螺丝Nobel Biocare ABK261147Neodent植入系统 - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC 兼容 Ti-BasesBioHorizons Implant Systems, 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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