FDA 510(k)

DESS 牙种植体

K号: K212538 · 2021-12-14

决定日期2021-12-14

产品代码DZE

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决定实质等同

器械摘要

DESS Dental Implants is the device name listed in this FDA 510(k) record. The listed applicant is Terrats Medical SL. It received FDA 510(k) clearance on 2021-12-14 under 510(k) number K212538. 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 DESS Dental Implants?

DESS Dental Implants is a medical device that received FDA 510(k) clearance on 2021-12-14. The listed applicant is Terrats Medical SL. The 510(k) number is K212538.

When did DESS Dental Implants receive FDA 510(k) clearance?

DESS Dental Implants received FDA 510(k) clearance on 2021-12-14, under 510(k) number K212538.

Who is the listed applicant for DESS Dental Implants?

The FDA 510(k) record lists Terrats Medical SL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DESS Dental Implants?

The FDA product code for DESS Dental Implants is DZE.

列明Terrats Medical SL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。

K260564DESS 牙种植体智能解决方案 K253804DESS 牙种植体智能解决方案 K251547DESS 牙种植体智能解决方案 K252384DESS® 牙种植体智能解决方案 K251280DESS® 牙种植体 K250639DESS 牙种植体智能解决方案

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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。