FDA 510(k)

Implacil 嵌入式系統

K 號：K202832 · 2021-05-26

申請人Implacil DE Bortoli Material Odontologico Ltda

決定日期2021-05-26

產品代碼DZE

諮詢委員會DE

決定相當於

器材摘要

Implacil Implant System is the device name listed in this FDA 510(k) record. The listed applicant is Implacil DE Bortoli Material Odontologico Ltda. It received FDA 510(k) clearance on 2021-05-26 under 510(k) number K202832. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Implacil Implant System?

Implacil Implant System is a medical device that received FDA 510(k) clearance on 2021-05-26. The listed applicant is Implacil DE Bortoli Material Odontologico Ltda. The 510(k) number is K202832.

When did Implacil Implant System receive FDA 510(k) clearance?

Implacil Implant System received FDA 510(k) clearance on 2021-05-26, under 510(k) number K202832.

Who is the listed applicant for Implacil Implant System?

The FDA 510(k) record lists Implacil DE Bortoli Material Odontologico Ltda as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Implacil Implant System?

The FDA product code for Implacil Implant System is DZE.

其他以 Implacil DE Bortoli Material Odontologico Ltda 為申請人之記錄

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K183024Implacil 嵌入式系統

相關器械（代碼：DZE）

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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官方來源

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