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FDA 510(k)

Nanova 2 齒科粘合劑步驟式鹽酸鹼洗，Nanova鹽酸鹼鹽酸鹼膠

K 號：K172977 · 2018-01-16

申請人Nanova Biomaterials, Inc.
決定日期2018-01-16
產品代碼KLE
諮詢委員會DE
決定相當於

器材摘要

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is the device name listed in this FDA 510(k) record. The listed applicant is Nanova Biomaterials, Inc.. It received FDA 510(k) clearance on 2018-01-16 under 510(k) number K172977. 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 Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is a medical device that received FDA 510(k) clearance on 2018-01-16. The listed applicant is Nanova Biomaterials, Inc.. The 510(k) number is K172977.

When did Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel receive FDA 510(k) clearance?

Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel received FDA 510(k) clearance on 2018-01-16, under 510(k) number K172977.

Who is the listed applicant for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

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

What is the FDA product code for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel?

The FDA product code for Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel is KLE.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Nanova Biomaterials, 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。

K171330Nanova 黏合劑K163672Nanova 螺旋釘縫合墊，Nanova 推入式縫合墊K161174諾瓦干擾螺釘K151943Vas-Q-Clip

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, LLCK260485Any-EtchMediclus Co., Ltd.K260430瓷刻膠Belport Company, Inc., Gingi-PakK252450Adhese 2Ivoclar Vivadent, Inc.K260682Bond-PR™ 過敏性膠粘劑Premier Dental Products CompanyK251587VITA VMLC 基質Vita Zahnfabrik H. Rauter GmbH & Co. Kg.

官方來源

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