FDA 510(k)

ABRO 1，RESITON GINGIVA，PRIME 和 THERAPON TRANSPA

K号: K200676 · 2020-07-08

决定日期2020-07-08

产品代码EBG

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决定实质等同

器械摘要

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn Srl. It received FDA 510(k) clearance on 2020-07-08 under 510(k) number K200676. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA?

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is a medical device that received FDA 510(k) clearance on 2020-07-08. The listed applicant is Zirkonzahn Srl. The 510(k) number is K200676.

When did ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA receive FDA 510(k) clearance?

ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA received FDA 510(k) clearance on 2020-07-08, under 510(k) number K200676.

Who is the listed applicant for ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA?

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

What is the FDA product code for ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA?

The FDA product code for ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA is EBG.

列明Zirkonzahn Srl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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