Premier 密封剂
K号: K161580 · 2016-10-18
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决定日期2016-10-18
产品代码EBC
咨询委员会DE
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决定实质等同
器械摘要
Premier Sealant 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 2016-10-18 under 510(k) number K161580. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Premier Sealant?
Premier Sealant is a medical device that received FDA 510(k) clearance on 2016-10-18. The listed applicant is Premier Dental Company Products. The 510(k) number is K161580.
When did Premier Sealant receive FDA 510(k) clearance?
Premier Sealant received FDA 510(k) clearance on 2016-10-18, under 510(k) number K161580.
Who is the listed applicant for Premier Sealant?
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 Premier Sealant?
The FDA product code for Premier Sealant is EBC.
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：EBC）
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。
K260819Any-Com 密封Mediclus Co., Ltd.K243254Parkell 龋齿和裂隙封闭剂Parkell, Inc.K232498UltraSeal XT plus - 由Nobio提供的生物防护，UltraSeal XT hydro - 由Nobio提供的生物防护Ultradent Product, Inc.K230455釉质涂层树脂Rizhao Huge Biomaterials Company, Ltd.K190998BA 凹陷与裂缝密封剂Apex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG
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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