X-cera 锆英石片
K号: K153767 · 2016-03-29
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决定日期2016-03-29
产品代码EIH
咨询委员会DE
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决定实质等同
器械摘要
X-cera Zirconia Blanks is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-03-29 under 510(k) number K153767. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the X-cera Zirconia Blanks?
X-cera Zirconia Blanks is a medical device that received FDA 510(k) clearance on 2016-03-29. The listed applicant is Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. The 510(k) number is K153767.
When did X-cera Zirconia Blanks receive FDA 510(k) clearance?
X-cera Zirconia Blanks received FDA 510(k) clearance on 2016-03-29, under 510(k) number K153767.
Who is the listed applicant for X-cera Zirconia Blanks?
The FDA 510(k) record lists Shenzhen Xiangtong Photoelectricity Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for X-cera Zirconia Blanks?
The FDA product code for X-cera Zirconia Blanks is EIH.
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相关器械（代码：EIH）
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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