AcceleDent Optima
K号: K170093 · 2017-05-26
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决定日期2017-05-26
产品代码OYH
咨询委员会DE
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器械摘要
AcceleDent Optima is the device name listed in this FDA 510(k) record. The listed applicant is Orthoaccel Technology, Inc.. It received FDA 510(k) clearance on 2017-05-26 under 510(k) number K170093. The device is classified under product code OYH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the AcceleDent Optima?
AcceleDent Optima is a medical device that received FDA 510(k) clearance on 2017-05-26. The listed applicant is Orthoaccel Technology, Inc.. The 510(k) number is K170093.
When did AcceleDent Optima receive FDA 510(k) clearance?
AcceleDent Optima received FDA 510(k) clearance on 2017-05-26, under 510(k) number K170093.
Who is the listed applicant for AcceleDent Optima?
The FDA 510(k) record lists Orthoaccel Technology, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for AcceleDent Optima?
The FDA product code for AcceleDent Optima is OYH.
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相关器械（代码：OYH）
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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