TheraCal DC
K号: K180344 · 2018-04-05
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申请人Bisco, Inc.
决定日期2018-04-05
产品代码EJK
咨询委员会DE
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决定实质等同
器械摘要
TheraCal DC is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2018-04-05 under 510(k) number K180344. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TheraCal DC?
TheraCal DC is a medical device that received FDA 510(k) clearance on 2018-04-05. The listed applicant is Bisco, Inc.. The 510(k) number is K180344.
When did TheraCal DC receive FDA 510(k) clearance?
TheraCal DC received FDA 510(k) clearance on 2018-04-05, under 510(k) number K180344.
Who is the listed applicant for TheraCal DC?
The FDA 510(k) record lists Bisco, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TheraCal DC?
The FDA product code for TheraCal DC is EJK.
相关临床试验
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列明Bisco, Inc.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：EJK）
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。
K261728一菲尔LCMediclus Co., Ltd.K253248设备名称：Bright腔内衬Dmp Dental Industry S.A.K2302703M® VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro 腔隙衬垫（Apacal ART，Cal LC，Calcigel，CalUltra）Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten 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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