BracePaste氟化物密封剂
K号: K242537 · 2024-08-27
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决定日期2024-08-27
产品代码DYH
咨询委员会DE
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决定实质等同
器械摘要
BracePaste Fluoride Sealant is the device name listed in this FDA 510(k) record. The listed applicant is American Orthodontics Corp.. It received FDA 510(k) clearance on 2024-08-27 under 510(k) number K242537. The device is classified under product code DYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the BracePaste Fluoride Sealant?
BracePaste Fluoride Sealant is a medical device that received FDA 510(k) clearance on 2024-08-27. The listed applicant is American Orthodontics Corp.. The 510(k) number is K242537.
When did BracePaste Fluoride Sealant receive FDA 510(k) clearance?
BracePaste Fluoride Sealant received FDA 510(k) clearance on 2024-08-27, under 510(k) number K242537.
Who is the listed applicant for BracePaste Fluoride Sealant?
The FDA 510(k) record lists American Orthodontics Corp. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BracePaste Fluoride Sealant?
The FDA product code for BracePaste Fluoride Sealant is DYH.
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。
相关器械（代码：DYH）
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。
K261129OrthoFitSpident Co., Ltd.K261840BracePaste Prime PlusAmerican OrthodonticsK250015Ormco® EtchFree Bonding System, Ormco® EtchFree Bonding Primer, Ormco® EtchFree AdhesiveOrmco CorporationK2340433M® Transbond® Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbHK214054TP 正畸光固化粘合剂系统，TP 正畸预应用粘合剂，TP 正畸蚀刻208520Tp Orthodontics, Inc.
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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