Tetric plus Fill;Tetric plus Flow
K号: K261485 · 2026-07-01
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决定日期2026-07-01
产品代码EBF
咨询委员会DE
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决定实质等同
器械摘要
Tetric plus Fill;Tetric plus Flow is the device name listed in this FDA 510(k) record. The listed applicant is Ivoclar Vivadent, Inc.. It received FDA 510(k) clearance on 2026-07-01 under 510(k) number K261485. 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 Tetric plus Fill;Tetric plus Flow?
Tetric plus Fill;Tetric plus Flow is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Ivoclar Vivadent, Inc.. The 510(k) number is K261485.
When did Tetric plus Fill;Tetric plus Flow receive FDA 510(k) clearance?
Tetric plus Fill;Tetric plus Flow received FDA 510(k) clearance on 2026-07-01, under 510(k) number K261485.
Who is the listed applicant for Tetric plus Fill;Tetric plus Flow?
The FDA 510(k) record lists Ivoclar Vivadent, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tetric plus Fill;Tetric plus Flow?
The FDA product code for Tetric plus Fill;Tetric plus Flow is EBF.
相关临床试验
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列明Ivoclar Vivadent, 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：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。
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