Any-Com 密封
K号: K260819 · 2026-05-01
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决定日期2026-05-01
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
Any-Com Seal is the device name listed in this FDA 510(k) record. The listed applicant is Mediclus Co., Ltd.. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K260819. 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 Any-Com Seal?
Any-Com Seal is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Mediclus Co., Ltd.. The 510(k) number is K260819.
When did Any-Com Seal receive FDA 510(k) clearance?
Any-Com Seal received FDA 510(k) clearance on 2026-05-01, under 510(k) number K260819.
Who is the listed applicant for Any-Com Seal?
FDA 510(k)记录将Mediclus Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Any-Com Seal?
The FDA product code for Any-Com Seal is EBC.
列明Mediclus Co., Ltd.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。
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, AGK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation
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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