FDA 510(k)

ABRO 1，RESITON GINGIVA，PRIME 和 THERAPON TRANSPA

K 號：K200676 · 2020-07-08

決定日期2020-07-08

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

其他以 Zirkonzahn Srl 為申請人之記錄

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相關器械（代碼：EBG）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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