Parkell 龋齿和裂隙封闭剂
K号: K243254 · 2025-08-08
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决定日期2025-08-08
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
Parkell Pit and Fissure Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K243254. 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 Parkell Pit and Fissure Sealant?
Parkell Pit and Fissure Sealant is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Parkell, Inc.. The 510(k) number is K243254.
When did Parkell Pit and Fissure Sealant receive FDA 510(k) clearance?
Parkell Pit and Fissure Sealant received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243254.
Who is the listed applicant for Parkell Pit and Fissure Sealant?
The FDA 510(k) record lists Parkell, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Parkell Pit and Fissure Sealant?
The FDA product code for Parkell Pit and Fissure 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Parkell, 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：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.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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