FDA 510(k)

全彩流

K 號：K193537 · 2020-08-19

決定日期2020-08-19

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Omnichroma Flow is the device name listed in this FDA 510(k) record. The listed applicant is Tokuyama Dental Corporation. It received FDA 510(k) clearance on 2020-08-19 under 510(k) number K193537. 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 Omnichroma Flow?

Omnichroma Flow is a medical device that received FDA 510(k) clearance on 2020-08-19. The listed applicant is Tokuyama Dental Corporation. The 510(k) number is K193537.

When did Omnichroma Flow receive FDA 510(k) clearance?

Omnichroma Flow received FDA 510(k) clearance on 2020-08-19, under 510(k) number K193537.

Who is the listed applicant for Omnichroma Flow?

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

What is the FDA product code for Omnichroma Flow?

The FDA product code for Omnichroma Flow is EBF.

其他以 Tokuyama Dental Corporation 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。

K203760東洋大學通用膠結劑II K203598Omnichroma Flow 大量 K190940東洋化學 Rebase III K180613Estelite 選擇性血流控制系統 K173275OMNICHROMA K171226TOKUYAMA UNIVERSAL BOND

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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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