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FDA 510(k)

Rennou™ 漆 (3% / 薄荷); Rennou™ 漆 (3% / 草莓); Rennou™ 漆 (3% / 樱桃); Rennou™ 漆 (3% / 气球糖)

K号: K243777 · 2025-05-27

申请人Theodent, LLC
决定日期2025-05-27
产品代码LBH
咨询委员会DE 请注意，您没有提供具体的医疗设备监管文本内容，因此我无法进行翻译。请提供需要翻译的具体文本，我将根据您的要求进行翻译。
决定实质等同

器械摘要

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) is the device name listed in this FDA 510(k) record. The listed applicant is Theodent, LLC. It received FDA 510(k) clearance on 2025-05-27 under 510(k) number K243777. 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 Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)?

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) is a medical device that received FDA 510(k) clearance on 2025-05-27. The listed applicant is Theodent, LLC. The 510(k) number is K243777.

When did Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) receive FDA 510(k) clearance?

Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) received FDA 510(k) clearance on 2025-05-27, under 510(k) number K243777.

Who is the listed applicant for Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)?

The FDA 510(k) record lists Theodent, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)?

The FDA product code for Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) is LBH.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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.K252073VOCO 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.

官方来源

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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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