FDA 510(k)

PuRE PMMA 盤片

K 號：K201563 · 2021-04-09

決定日期2021-04-09

產品代碼EBG

諮詢委員會DE

決定相當於

器材摘要

PuRE PMMA Disc is the device name listed in this FDA 510(k) record. The listed applicant is Quest Dental USA Corp.. It received FDA 510(k) clearance on 2021-04-09 under 510(k) number K201563. 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 PuRE PMMA Disc?

PuRE PMMA Disc is a medical device that received FDA 510(k) clearance on 2021-04-09. The listed applicant is Quest Dental USA Corp.. The 510(k) number is K201563.

When did PuRE PMMA Disc receive FDA 510(k) clearance?

PuRE PMMA Disc received FDA 510(k) clearance on 2021-04-09, under 510(k) number K201563.

Who is the listed applicant for PuRE PMMA Disc?

The FDA 510(k) record lists Quest Dental USA Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PuRE PMMA Disc?

The FDA product code for PuRE PMMA Disc is EBG.

其他以 Quest Dental USA Corp. 為申請人之記錄

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。

K172281PuRE PMMA 盤片

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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官方來源

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