FDA 510(k)

Bond-PR™ 過敏性膠粘劑

K 號：K260682 · 2026-03-03

決定日期2026-03-03

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

Bond-PR™ Universal Adhesive is the device name listed in this FDA 510(k) record. The listed applicant is Premier Dental Products Company. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K260682. 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 Bond-PR™ Universal Adhesive?

Bond-PR™ Universal Adhesive is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Premier Dental Products Company. The 510(k) number is K260682.

When did Bond-PR™ Universal Adhesive receive FDA 510(k) clearance?

Bond-PR™ Universal Adhesive received FDA 510(k) clearance on 2026-03-03, under 510(k) number K260682.

Who is the listed applicant for Bond-PR™ Universal Adhesive?

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

What is the FDA product code for Bond-PR™ Universal Adhesive?

The FDA product code for Bond-PR™ Universal Adhesive is KLE.

其他以 Premier Dental Products Company 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。

K253513多匹配流蜥蜴抗菌複合材 K223632領先者多合一口罩變色修復複合材料

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.K251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.K252151els unibondSaremco Dental AG

官方來源

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