氟化物漆（类型A，类型C）
K号: K253052 · 2026-06-11
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决定日期2026-06-11
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
Fluoride Varnish (Type A,Type C) is the device name listed in this FDA 510(k) record. The listed applicant is Nagy Oral Technology Qinhuangdao Co., Ltd.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253052. 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 Fluoride Varnish (Type A,Type C)?
Fluoride Varnish (Type A,Type C) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Nagy Oral Technology Qinhuangdao Co., Ltd.. The 510(k) number is K253052.
When did Fluoride Varnish (Type A,Type C) receive FDA 510(k) clearance?
Fluoride Varnish (Type A,Type C) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253052.
Who is the listed applicant for Fluoride Varnish (Type A,Type C)?
The FDA 510(k) record lists Nagy Oral Technology Qinhuangdao Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fluoride Varnish (Type A,Type C)?
The FDA product code for Fluoride Varnish (Type A,Type C) is LBH.
相关临床试验
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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. KGK252073VOCO Profluorid 漱口水 + BioMinVoco GmbHK261404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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