FDA 510(k)

Venus 大流量 ONE

K 號：K220605 · 2022-04-21

決定日期2022-04-21

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Venus Bulk Flow ONE is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K220605. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Venus Bulk Flow ONE?

Venus Bulk Flow ONE is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Kulzer, LLC. The 510(k) number is K220605.

When did Venus Bulk Flow ONE receive FDA 510(k) clearance?

Venus Bulk Flow ONE received FDA 510(k) clearance on 2022-04-21, under 510(k) number K220605.

Who is the listed applicant for Venus Bulk Flow ONE?

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

What is the FDA product code for Venus Bulk Flow ONE?

The FDA product code for Venus Bulk Flow ONE is EBF.

其他以 Kulzer, LLC 為申請人之記錄

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K260783Venus 鑫石；Venus 鑫石流；Venus 珍珠；Venus 大量流 One K254063iCEM大規模通用版 K243910Retraxil K240660Signum複合流；Signum通用粘合劑；Signum金屬粘合劑；Signum複合；Signum矩陣；Signum液體；Signum cre-active K233868dima 印刷牙齒與溫度計 K230644Signum不透明F

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相關器械（代碼：EBF）

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

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