Insight Dental System
K号: K170211 · 2017-04-27
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决定日期2017-04-27
产品代码DZE
咨询委员会DE
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决定实质等同
器械摘要
Insight Dental System is the device name listed in this FDA 510(k) record. The listed applicant is Insight Dental System. It received FDA 510(k) clearance on 2017-04-27 under 510(k) number K170211. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Insight Dental System?
Insight Dental System is a medical device that received FDA 510(k) clearance on 2017-04-27. The listed applicant is Insight Dental System. The 510(k) number is K170211.
When did Insight Dental System receive FDA 510(k) clearance?
Insight Dental System received FDA 510(k) clearance on 2017-04-27, under 510(k) number K170211.
Who is the listed applicant for Insight Dental System?
The FDA 510(k) record lists Insight Dental System as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Insight Dental System?
The FDA product code for Insight Dental System is DZE.
相关临床试验
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相关器械（代码：DZE）
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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