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K号: K201795 · 2020-09-28
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决定日期2020-09-28
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
Transcend is the device name listed in this FDA 510(k) record. The listed applicant is Ultradent Product, Inc.. It received FDA 510(k) clearance on 2020-09-28 under 510(k) number K201795. 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 Transcend?
Transcend is a medical device that received FDA 510(k) clearance on 2020-09-28. The listed applicant is Ultradent Product, Inc.. The 510(k) number is K201795.
When did Transcend receive FDA 510(k) clearance?
Transcend received FDA 510(k) clearance on 2020-09-28, under 510(k) number K201795.
Who is the listed applicant for Transcend?
The FDA 510(k) record lists Ultradent Product, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Transcend?
The FDA product code for Transcend is EBF.
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Ultradent Product, 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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