FDA 510(k)

els unibond

K 號：K252151 · 2025-12-05

決定日期2025-12-05

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

els unibond is the device name listed in this FDA 510(k) record. The listed applicant is Saremco Dental AG. It received FDA 510(k) clearance on 2025-12-05 under 510(k) number K252151. 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 els unibond?

els unibond is a medical device that received FDA 510(k) clearance on 2025-12-05. The listed applicant is Saremco Dental AG. The 510(k) number is K252151.

When did els unibond receive FDA 510(k) clearance?

els unibond received FDA 510(k) clearance on 2025-12-05, under 510(k) number K252151.

Who is the listed applicant for els unibond?

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

What is the FDA product code for els unibond?

The FDA product code for els unibond is KLE.

其他以 Saremco Dental AG 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。

K240823els超低縮水率®複合材料 & els超低縮水率®流體 K232050saremco 印刷 BRIDGETEC K213343Saremco Print CROWNTEC

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.

官方來源

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