Quantum LB
K号: K161684 · 2016-10-06
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决定日期2016-10-06
产品代码DYH
咨询委员会DE
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器械摘要
Quantum LB 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 2016-10-06 under 510(k) number K161684. 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 Quantum LB?
Quantum LB is a medical device that received FDA 510(k) clearance on 2016-10-06. The listed applicant is Reliance Orthodontic Products, Inc.. The 510(k) number is K161684.
When did Quantum LB receive FDA 510(k) clearance?
Quantum LB received FDA 510(k) clearance on 2016-10-06, under 510(k) number K161684.
Who is the listed applicant for Quantum LB?
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 Quantum LB?
The FDA product code for Quantum LB is DYH.
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：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 CorporationK242537BracePaste氟化物密封剂American Orthodontics Corp.K2340433M® Transbond® Orthodontic Adhesive3M Unitek Orthodontic ProductsK231817AlignerFlow LCVoco GmbH
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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