FDA 510(k)

RC-Prime根管準備膠膏

K 號：K200330 · 2020-07-06

決定日期2020-07-06

產品代碼KJJ

決定相當於

器材摘要

RC-Prime Root Canal Preparation Cream is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2020-07-06 under 510(k) number K200330. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

常見問題

What is the RC-Prime Root Canal Preparation Cream?

RC-Prime Root Canal Preparation Cream is a medical device that received FDA 510(k) clearance on 2020-07-06. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K200330.

When did RC-Prime Root Canal Preparation Cream receive FDA 510(k) clearance?

RC-Prime Root Canal Preparation Cream received FDA 510(k) clearance on 2020-07-06, under 510(k) number K200330.

Who is the listed applicant for RC-Prime Root Canal Preparation Cream?

The FDA 510(k) record lists Pac-Dent, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RC-Prime Root Canal Preparation Cream?

The FDA product code for RC-Prime Root Canal Preparation Cream is KJJ.

其他以 Pac-Dent, Inc. 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。

K202674Medidenta 高速手持式工具 K202920OptiComp K202831The iMask 優兒童臉部口罩 K210189Pac-Dent 義齒基底樹脂 K210412Pac-Dent 鈷酸鹽纳米雙組合树脂 K210186PacBond One

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相關器械（代碼：KJJ）

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。

K250279RC-SwiftPrepBelport Company, Inc., Gingi-Pak K241354密封劑溶劑Inter-Med, Inc.K201785EPIEN 牙齒清潔器Epien Medical, Inc.K211813海神Inter-Med / Vista Dental K193357V-MixInter-Med/Vista Dental Products K193409視野清潔器，視野清潔器加強版Inter-Med/Vista Dental Products

官方來源

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