FDA 510(k)

清潔凈化器

K 號：K201799 · 2021-02-12

決定日期2021-02-12

產品代碼EJK

諮詢委員會DE

決定相當於

器材摘要

CleaniCal is the device name listed in this FDA 510(k) record. The listed applicant is Maruchi. It received FDA 510(k) clearance on 2021-02-12 under 510(k) number K201799. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CleaniCal?

CleaniCal is a medical device that received FDA 510(k) clearance on 2021-02-12. The listed applicant is Maruchi. The 510(k) number is K201799.

When did CleaniCal receive FDA 510(k) clearance?

CleaniCal received FDA 510(k) clearance on 2021-02-12, under 510(k) number K201799.

Who is the listed applicant for CleaniCal?

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

What is the FDA product code for CleaniCal?

The FDA product code for CleaniCal is EJK.

其他以 Maruchi 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。

K213757Endocem MTA 預混標準型 K212229白端封釋MTA K202015白 ENDOSEAL MTA K170175ENDOSEAL MTA

相關器械（代碼：EJK）

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。

K261728One-Fil LCMediclus Co., Ltd.K253248明亮腔道覆蓋物Dmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental Products K212475Prevest Denpro 腺體洞線材（Apacal ART、Cal LC、Calcigel、CalUltra）Prevest Denpro Limited K202413LC 树脂計算器 PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH K191103帕克爾敏感去除膠Parkell, Inc.

官方來源

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