FDA 510(k)

融合粘合5，融合理510(k)，融合理DC，更新MDP，更新通用

K 號：K231696 · 2023-08-11

決定日期2023-08-11

產品代碼KLE

諮詢委員會DE

決定相當於

器材摘要

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is the device name listed in this FDA 510(k) record. The listed applicant is Prevest Denpro Limited. It received FDA 510(k) clearance on 2023-08-11 under 510(k) number K231696. 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 Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is a medical device that received FDA 510(k) clearance on 2023-08-11. The listed applicant is Prevest Denpro Limited. The 510(k) number is K231696.

When did Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal receive FDA 510(k) clearance?

Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal received FDA 510(k) clearance on 2023-08-11, under 510(k) number K231696.

Who is the listed applicant for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

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

What is the FDA product code for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal?

The FDA product code for Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal is KLE.

其他以 Prevest Denpro Limited 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。

K233273C&B陶瓷；C&B永久；C&B臨時 K231263融合核心直流 Flo；融合 Flo；融合 Flo SE；融合 1 密封；Magna NT K213244Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)K212563CalApex Calplus、Cerafill RCS、Endoseal、Nanoseal S、Zical Ultra 黏土、Zical Ultra 粉末/液體 K212475Prevest Denpro 腺體洞線材（Apacal ART、Cal LC、Calcigel、CalUltra）K200555Prevest Denpro 齒科膠水（Micron 生物活性膠水、Micron 高級膠水、Micron 高級膠水膠囊、Micron 黏合膠水、Micron 齒質調理劑）

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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.

官方來源

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