KDF氧化锆圆盘
K号: K221429 · 2022-07-14
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决定日期2022-07-14
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
KDF Zirconia Disc is the device name listed in this FDA 510(k) record. The listed applicant is Denken-Highdental Co., Ltd.. It received FDA 510(k) clearance on 2022-07-14 under 510(k) number K221429. 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 KDF Zirconia Disc?
KDF Zirconia Disc is a medical device that received FDA 510(k) clearance on 2022-07-14. The listed applicant is Denken-Highdental Co., Ltd.. The 510(k) number is K221429.
When did KDF Zirconia Disc receive FDA 510(k) clearance?
KDF Zirconia Disc received FDA 510(k) clearance on 2022-07-14, under 510(k) number K221429.
Who is the listed applicant for KDF Zirconia Disc?
The FDA 510(k) record lists Denken-Highdental Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for KDF Zirconia Disc?
The FDA product code for KDF Zirconia Disc is EIH.
相关临床试验
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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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