FDA 510(k)

P1145 牙齒修復設備

K 號：K162257 · 2016-11-07

決定日期2016-11-07

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

P1145 Dental Restorative is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation. It received FDA 510(k) clearance on 2016-11-07 under 510(k) number K162257. 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 P1145 Dental Restorative?

P1145 Dental Restorative is a medical device that received FDA 510(k) clearance on 2016-11-07. The listed applicant is Kerr Corporation. The 510(k) number is K162257.

When did P1145 Dental Restorative receive FDA 510(k) clearance?

P1145 Dental Restorative received FDA 510(k) clearance on 2016-11-07, under 510(k) number K162257.

Who is the listed applicant for P1145 Dental Restorative?

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

What is the FDA product code for P1145 Dental Restorative?

The FDA product code for P1145 Dental Restorative is EBF.

其他以 Kerr 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。

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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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