Orthodontic Acrylic 2
K号: K163482 · 2017-05-31
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决定日期2017-05-31
产品代码EBI
咨询委员会DE
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器械摘要
Orthodontic Acrylic 2 is the device name listed in this FDA 510(k) record. The listed applicant is Lang Dental Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2017-05-31 under 510(k) number K163482. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Orthodontic Acrylic 2?
Orthodontic Acrylic 2 is a medical device that received FDA 510(k) clearance on 2017-05-31. The listed applicant is Lang Dental Manufacturing Co., Inc.. The 510(k) number is K163482.
When did Orthodontic Acrylic 2 receive FDA 510(k) clearance?
Orthodontic Acrylic 2 received FDA 510(k) clearance on 2017-05-31, under 510(k) number K163482.
Who is the listed applicant for Orthodontic Acrylic 2?
The FDA 510(k) record lists Lang Dental Manufacturing Co., Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Orthodontic Acrylic 2?
The FDA product code for Orthodontic Acrylic 2 is EBI.
相关临床试验
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相关器械（代码：EBI）
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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