TKO复合咬合涡轮凝胶
K号: K210349 · 2021-07-20
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决定日期2021-07-20
产品代码EBF
咨询委员会DE
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决定实质等同
器械摘要
TKO Composite Bite Turbo Gel is the device name listed in this FDA 510(k) record. The listed applicant is Reliance Orthodontic Products, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) number K210349. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the TKO Composite Bite Turbo Gel?
TKO Composite Bite Turbo Gel is a medical device that received FDA 510(k) clearance on 2021-07-20. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K210349.
When did TKO Composite Bite Turbo Gel receive FDA 510(k) clearance?
TKO Composite Bite Turbo Gel received FDA 510(k) clearance on 2021-07-20, under 510(k) number K210349.
Who is the listed applicant for TKO Composite Bite Turbo Gel?
The FDA 510(k) record lists Reliance Orthodontic Products, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for TKO Composite Bite Turbo Gel?
The FDA product code for TKO Composite Bite Turbo Gel is EBF.
相关临床试验
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列明Reliance Orthodontic Products, 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：EBF）
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。
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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