EPIEN 牙科清洁剂
K号: K201785 · 2021-09-09
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器械摘要
EPIEN Dental Cleanser is the device name listed in this FDA 510(k) record. The listed applicant is Epien Medical, Inc.. It received FDA 510(k) clearance on 2021-09-09 under 510(k) number K201785. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.
常见问题
What is the EPIEN Dental Cleanser?
EPIEN Dental Cleanser is a medical device that received FDA 510(k) clearance on 2021-09-09. The listed applicant is Epien Medical, Inc.. The 510(k) number is K201785.
When did EPIEN Dental Cleanser receive FDA 510(k) clearance?
EPIEN Dental Cleanser received FDA 510(k) clearance on 2021-09-09, under 510(k) number K201785.
Who is the listed applicant for EPIEN Dental Cleanser?
The FDA 510(k) record lists Epien Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for EPIEN Dental Cleanser?
The FDA product code for EPIEN Dental Cleanser is KJJ.
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。
相关器械(代码:KJJ)
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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