FDA 510(k)

BASIS FLOW II

K 號：K233859 · 2024-03-05

決定日期2024-03-05

產品代碼EBI

諮詢委員會DE

決定相當於

器材摘要

BASIS FLOW II is the device name listed in this FDA 510(k) record. The listed applicant is YAMAHACHI DENTAL MFG., Co.. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K233859. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the BASIS FLOW II?

BASIS FLOW II is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is YAMAHACHI DENTAL MFG., Co.. The 510(k) number is K233859.

When did BASIS FLOW II receive FDA 510(k) clearance?

BASIS FLOW II received FDA 510(k) clearance on 2024-03-05, under 510(k) number K233859.

Who is the listed applicant for BASIS FLOW II?

The FDA 510(k) record lists YAMAHACHI DENTAL MFG., Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BASIS FLOW II?

The FDA product code for BASIS FLOW II is EBI.

其他以 YAMAHACHI DENTAL MFG., Co. 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。

K254091亮麗塗層（15ML）K172683山鹿粉紅 CAD/CAM 盤

相關器械（代碼：EBI）

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。

K261802Glidewell™ 牙托基材膠Prismatik Dentalcraft, Inc.K261626超印柔軟假牙紫外線Guangzhou Heygears IMC., Inc.K262681奈米瓷膠膠黏劑3BFAB TEKNOLOJI A.S.K262300假牙基座膠 V2Formlabs Ohio, Inc.K261474DENTCA 真柔軟Dentca, Inc.K260569DB 4000 高衝擊牙托基座Carbon, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。