AeroPro 无线抛光系统
K号: K180682 · 2019-02-27
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决定日期2019-02-27
产品代码EKX
咨询委员会DE
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决定实质等同
器械摘要
AeroPro Cordless Prophy System is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Company Products. It received FDA 510(k) clearance on 2019-02-27 under 510(k) number K180682. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AeroPro Cordless Prophy System?
AeroPro Cordless Prophy System is a medical device that received FDA 510(k) clearance on 2019-02-27. The listed applicant is Premier Dental Company Products. The 510(k) number is K180682.
When did AeroPro Cordless Prophy System receive FDA 510(k) clearance?
AeroPro Cordless Prophy System received FDA 510(k) clearance on 2019-02-27, under 510(k) number K180682.
Who is the listed applicant for AeroPro Cordless Prophy System?
The FDA 510(k) record lists Premier Dental Company Products as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AeroPro Cordless Prophy System?
The FDA product code for AeroPro Cordless Prophy System is EKX.
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Premier Dental Company Products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：EKX）
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。
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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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