E-Dent 1000
K号: K210977 · 2021-05-25
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决定日期2021-05-25
产品代码EBF
咨询委员会DE
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器械摘要
E-Dent 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-05-25 under 510(k) number K210977. 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 E-Dent 1000?
E-Dent 1000 is a medical device that received FDA 510(k) clearance on 2021-05-25. The listed applicant is Envisiontec GmbH. The 510(k) number is K210977.
When did E-Dent 1000 receive FDA 510(k) clearance?
E-Dent 1000 received FDA 510(k) clearance on 2021-05-25, under 510(k) number K210977.
Who is the listed applicant for E-Dent 1000?
The FDA 510(k) record lists Envisiontec GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for E-Dent 1000?
The FDA product code for E-Dent 1000 is EBF.
列明Envisiontec GmbH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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