Franz氧化锆牙冠
K号: K203072 · 2022-01-19
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决定日期2022-01-19
产品代码ELL
咨询委员会DE
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决定实质等同
器械摘要
Franz Zirconia Dental Crown is the device name listed in this FDA 510(k) record. The listed applicant is Franz Biotech, Inc.. It received FDA 510(k) clearance on 2022-01-19 under 510(k) number K203072. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Franz Zirconia Dental Crown?
Franz Zirconia Dental Crown is a medical device that received FDA 510(k) clearance on 2022-01-19. The listed applicant is Franz Biotech, Inc.. The 510(k) number is K203072.
When did Franz Zirconia Dental Crown receive FDA 510(k) clearance?
Franz Zirconia Dental Crown received FDA 510(k) clearance on 2022-01-19, under 510(k) number K203072.
Who is the listed applicant for Franz Zirconia Dental Crown?
The FDA 510(k) record lists Franz Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Franz Zirconia Dental Crown?
The FDA product code for Franz Zirconia Dental Crown is ELL.
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。
相关器械（代码：ELL）
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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