VOCO Profluorid 漱口水 + BioMin
K号: K252073 · 2026-05-01
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申请人Voco GmbH
决定日期2026-05-01
产品代码LBH
咨询委员会DE
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决定实质等同
器械摘要
VOCO Profluorid Varnish + BioMin is the device name listed in this FDA 510(k) record. The listed applicant is Voco GmbH. It received FDA 510(k) clearance on 2026-05-01 under 510(k) number K252073. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the VOCO Profluorid Varnish + BioMin?
VOCO Profluorid Varnish + BioMin is a medical device that received FDA 510(k) clearance on 2026-05-01. The listed applicant is Voco GmbH. The 510(k) number is K252073.
When did VOCO Profluorid Varnish + BioMin receive FDA 510(k) clearance?
VOCO Profluorid Varnish + BioMin received FDA 510(k) clearance on 2026-05-01, under 510(k) number K252073.
Who is the listed applicant for VOCO Profluorid Varnish + BioMin?
The FDA 510(k) record lists Voco GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VOCO Profluorid Varnish + BioMin?
The FDA product code for VOCO Profluorid Varnish + BioMin is LBH.
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列明Voco GmbH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：LBH）
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。
K262243Profisil FreeKettenbach GmbH & Co. KGK253052氟化物漆（类型A，类型C）Nagy Oral Technology Qinhuangdao Co., Ltd.K261404超易用Ultradent Products, Inc.K260830APAPRO 家用脱敏剂（再矿化抗敏感牙膏）Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, Inc.K243777Rennou™ 漆 (3% / 薄荷); Rennou™ 漆 (3% / 草莓); Rennou™ 漆 (3% / 樱桃); Rennou™ 漆 (3% / 气球糖)Theodent, LLC
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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