SHOFU 树脂釉
K号: K163568 · 2017-08-16
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决定日期2017-08-16
产品代码EBD
咨询委员会DE
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决定实质等同
器械摘要
SHOFU RESIN GLAZE 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 2017-08-16 under 510(k) number K163568. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SHOFU RESIN GLAZE?
SHOFU RESIN GLAZE is a medical device that received FDA 510(k) clearance on 2017-08-16. The listed applicant is Shofu Dental Corporation. The 510(k) number is K163568.
When did SHOFU RESIN GLAZE receive FDA 510(k) clearance?
SHOFU RESIN GLAZE received FDA 510(k) clearance on 2017-08-16, under 510(k) number K163568.
Who is the listed applicant for SHOFU RESIN GLAZE?
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 SHOFU RESIN GLAZE?
The FDA product code for SHOFU RESIN GLAZE is EBD.
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：EBD）
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。
K254091GLOSSY COAT (15ML)YAMAHACHI DENTAL MFG., Co.K250804ID LIGHT 照明系统Id Korea Co., Ltd.K240735visio.lign 颜色，visio.lign 防护罩Bredent GmbH & Co. KGK223365RODIN自然化套件Belport Company, Inc., Gingi-PakK211854VITA Akzent LCVita Zahnfabrik GmbH H Rauter & COK162408表面纳米清漆，Plaquit，LightpaintDreve Dentamid GmbH
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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