FDA 510(k)

All-Bond Universal w/BAC (not finalized)

K 號：K161051 · 2016-09-09

決定日期2016-09-09

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

All-Bond Universal w/BAC (not finalized) is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 2016-09-09 under 510(k) number K161051. The device is classified under product code KLE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the All-Bond Universal w/BAC (not finalized)?

All-Bond Universal w/BAC (not finalized) is a medical device that received FDA 510(k) clearance on 2016-09-09. The listed applicant is Bisco, Inc.. The 510(k) number is K161051.

When did All-Bond Universal w/BAC (not finalized) receive FDA 510(k) clearance?

All-Bond Universal w/BAC (not finalized) received FDA 510(k) clearance on 2016-09-09, under 510(k) number K161051.

Who is the listed applicant for All-Bond Universal w/BAC (not finalized)?

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

What is the FDA product code for All-Bond Universal w/BAC (not finalized)?

The FDA product code for All-Bond Universal w/BAC (not finalized) is KLE.

其他以 Bisco, Inc. 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：KLE）

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。

K262252MPa 最大膠粘劑Den-Mat Holdings, LLC K260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-Pak K252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products Company K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

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