DENTCA 假牙牙齿
K号: K172398 · 2017-11-22
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申请人Dentca, Inc.
决定日期2017-11-22
产品代码PZY
咨询委员会DE
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决定实质等同
器械摘要
DENTCA DENTURE Teeth is the device name listed in this FDA 510(k) record. The listed applicant is Dentca, Inc.. It received FDA 510(k) clearance on 2017-11-22 under 510(k) number K172398. The device is classified under product code PZY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the DENTCA DENTURE Teeth?
DENTCA DENTURE Teeth is a medical device that received FDA 510(k) clearance on 2017-11-22. The listed applicant is Dentca, Inc.. The 510(k) number is K172398.
When did DENTCA DENTURE Teeth receive FDA 510(k) clearance?
DENTCA DENTURE Teeth received FDA 510(k) clearance on 2017-11-22, under 510(k) number K172398.
Who is the listed applicant for DENTCA DENTURE Teeth?
The FDA 510(k) record lists Dentca, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for DENTCA DENTURE Teeth?
The FDA product code for DENTCA DENTURE Teeth is PZY.
相关临床试验
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。
列明Dentca, 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。
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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