BeautiBond Xtreme
K号: K213965 · 2022-03-18
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决定日期2022-03-18
产品代码KLE
咨询委员会DE
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决定实质等同
器械摘要
BeautiBond Xtreme is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corporation. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K213965. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BeautiBond Xtreme?
BeautiBond Xtreme is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Shofu Dental Corporation. The 510(k) number is K213965.
When did BeautiBond Xtreme receive FDA 510(k) clearance?
BeautiBond Xtreme received FDA 510(k) clearance on 2022-03-18, under 510(k) number K213965.
Who is the listed applicant for BeautiBond Xtreme?
The FDA 510(k) record lists Shofu Dental Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BeautiBond Xtreme?
The FDA product code for BeautiBond Xtreme is KLE.
相关临床试验
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列明Shofu Dental Corporation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：KLE）
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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