FDA 510(k)

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment

K 號：K231338 · 2023-05-10

決定日期2023-05-10

產品代碼LBH

諮詢委員會DE

決定相當於

器材摘要

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is the device name listed in this FDA 510(k) record. The listed applicant is 3M Espe Dental Products. It received FDA 510(k) clearance on 2023-05-10 under 510(k) number K231338. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment?

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is a medical device that received FDA 510(k) clearance on 2023-05-10. The listed applicant is 3M Espe Dental Products. The 510(k) number is K231338.

When did 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment receive FDA 510(k) clearance?

3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment received FDA 510(k) clearance on 2023-05-10, under 510(k) number K231338.

Who is the listed applicant for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment?

The FDA 510(k) record lists 3M Espe Dental Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment?

The FDA product code for 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment is LBH.

其他以 3M Espe Dental Products 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。

K2302703M™ VitCal Liner/Base K1911223M RelyX 優兒童樹脂改進玻璃離子鹽水泥 K1834763M Filtek Universal 修復材料

相關器械（代碼：LBH）

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。

K262243Profisil 免費Kettenbach GmbH & Co. KG K253052氟化膠漆（A型，C型）Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbH K261404超輕易Ultradent Products, Inc.K260830APAPRO Desensitizer Homecare (再礦化抗敏感牙膏)Sangi Co., Ltd.K250714氟量膠漆Centrix, Inc.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。