FDA 510(k)

S.I.N. 牙齿种植系统

K号: K221453 · 2022-12-15

申请人S.I.N. – Sistema DE Implante Nacional S.A.

决定日期2022-12-15

产品代码DZE

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决定实质等同

器械摘要

S.I.N. Dental Implant System is the device name listed in this FDA 510(k) record. The listed applicant is S.I.N. – Sistema DE Implante Nacional S.A.. It received FDA 510(k) clearance on 2022-12-15 under 510(k) number K221453. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the S.I.N. Dental Implant System?

S.I.N. Dental Implant System is a medical device that received FDA 510(k) clearance on 2022-12-15. The listed applicant is S.I.N. – Sistema DE Implante Nacional S.A.. The 510(k) number is K221453.

When did S.I.N. Dental Implant System receive FDA 510(k) clearance?

S.I.N. Dental Implant System received FDA 510(k) clearance on 2022-12-15, under 510(k) number K221453.

Who is the listed applicant for S.I.N. Dental Implant System?

The FDA 510(k) record lists S.I.N. – Sistema DE Implante Nacional S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S.I.N. Dental Implant System?

The FDA product code for S.I.N. Dental Implant System is DZE.

列明S.I.N. – Sistema DE Implante Nacional S.A.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。

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官方来源

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