FDA 510(k)

N1 TiUltra TCC 植入系统

K号: K211109 · 2021-12-21

决定日期2021-12-21

产品代码DZE

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决定实质等同

器械摘要

N1 TiUltra TCC Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Nobel Biocare Services AG. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K211109. 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 N1 TiUltra TCC Implant System?

N1 TiUltra TCC Implant System is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Nobel Biocare Services AG. The 510(k) number is K211109.

When did N1 TiUltra TCC Implant System receive FDA 510(k) clearance?

N1 TiUltra TCC Implant System received FDA 510(k) clearance on 2021-12-21, under 510(k) number K211109.

Who is the listed applicant for N1 TiUltra TCC Implant System?

The FDA 510(k) record lists Nobel Biocare Services AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for N1 TiUltra TCC Implant System?

The FDA product code for N1 TiUltra TCC Implant System is DZE.

列明Nobel Biocare Services AG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。

K231219NobelZygoma PureSet™ 盘 K220339Esthetic Abutments Nobel Biocare N1 K220048NobelProcera 氧化锆 N1 底座 K212932Nobel Biocare NobelSpeedy Groovy / Branemark 系统Mk III TiUnite / Replace Select TC PureSet 盘

官方来源

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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。