FDA 510(k)

PacEndo EDTA

K 號：K153528 · 2016-02-01

決定日期2016-02-01

產品代碼KJJ

決定相當於

器材摘要

PacEndo EDTA is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent International, Inc.. It received FDA 510(k) clearance on 2016-02-01 under 510(k) number K153528. The device is classified under product code KJJ. FDA Decision: Substantially Equivalent.

常見問題

What is the PacEndo EDTA?

PacEndo EDTA is a medical device that received FDA 510(k) clearance on 2016-02-01. The listed applicant is Pac-Dent International, Inc.. The 510(k) number is K153528.

When did PacEndo EDTA receive FDA 510(k) clearance?

PacEndo EDTA received FDA 510(k) clearance on 2016-02-01, under 510(k) number K153528.

Who is the listed applicant for PacEndo EDTA?

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

What is the FDA product code for PacEndo EDTA?

The FDA product code for PacEndo EDTA is KJJ.

其他以 Pac-Dent International, 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。

K162662GingiDent 牙齦拉退膠 K160577PacEndo 樂菌定 K151123Pac-Dent 防護套筒，Cover-It™ 防護膠膜

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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