CELTRA Press
K号: K161269 · 2016-08-12
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器械摘要
CELTRA Press is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Sirona. It received FDA 510(k) clearance on 2016-08-12 under 510(k) number K161269. 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 CELTRA Press?
CELTRA Press is a medical device that received FDA 510(k) clearance on 2016-08-12. The listed applicant is Dentsply Sirona. The 510(k) number is K161269.
When did CELTRA Press receive FDA 510(k) clearance?
CELTRA Press received FDA 510(k) clearance on 2016-08-12, under 510(k) number K161269.
Who is the listed applicant for CELTRA Press?
The FDA 510(k) record lists Dentsply Sirona as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for CELTRA Press?
The FDA product code for CELTRA Press is EIH.
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列明Dentsply Sirona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：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。
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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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