FDA 510(k)

Riva Cem Automix

K 號：K214118 · 2022-08-30

決定日期2022-08-30

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

Riva Cem Automix is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Limited. It received FDA 510(k) clearance on 2022-08-30 under 510(k) number K214118. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Riva Cem Automix?

Riva Cem Automix is a medical device that received FDA 510(k) clearance on 2022-08-30. The listed applicant is Sdi Limited. The 510(k) number is K214118.

When did Riva Cem Automix receive FDA 510(k) clearance?

Riva Cem Automix received FDA 510(k) clearance on 2022-08-30, under 510(k) number K214118.

Who is the listed applicant for Riva Cem Automix?

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

What is the FDA product code for Riva Cem Automix?

The FDA product code for Riva Cem Automix is EMA.

其他以 Sdi Limited 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。

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相關器械（代碼：EMA）

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。

K262983EsTemp 偽裝體Spident Co., Ltd.K254201任何-瓷Mediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-Pak K261166DIA-CEMDiaDent Group International K254109G-CEM 大眾化GC America, Inc.K253337REGEN 生物活性水泥Inter-Med, Inc.

官方來源

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