FDA 510(k)

BioHPP - breCAM.BioHPP

K 號：K152113 · 2016-07-21

決定日期2016-07-21

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

BioHPP - breCAM.BioHPP is the device name listed in this FDA 510(k) record. The listed applicant is Bredent GmbH & Co. KG. It received FDA 510(k) clearance on 2016-07-21 under 510(k) number K152113. 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 BioHPP - breCAM.BioHPP?

BioHPP - breCAM.BioHPP is a medical device that received FDA 510(k) clearance on 2016-07-21. The listed applicant is Bredent GmbH & Co. KG. The 510(k) number is K152113.

When did BioHPP - breCAM.BioHPP receive FDA 510(k) clearance?

BioHPP - breCAM.BioHPP received FDA 510(k) clearance on 2016-07-21, under 510(k) number K152113.

Who is the listed applicant for BioHPP - breCAM.BioHPP?

The FDA 510(k) record lists Bredent GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioHPP - breCAM.BioHPP?

The FDA product code for BioHPP - breCAM.BioHPP is EBF.

其他以 Bredent GmbH & Co. KG 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。

K240735visio.lign 颜色，visio.lign 盾

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

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。