FDA 510(k)

氟量膠漆

K 號：K250714 · 2025-11-21

決定日期2025-11-21

產品代碼LBH

諮詢委員會DE

決定相當於

器材摘要

FluoroDose Varnish is the device name listed in this FDA 510(k) record. The listed applicant is Centrix, Inc.. It received FDA 510(k) clearance on 2025-11-21 under 510(k) number K250714. 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 FluoroDose Varnish?

FluoroDose Varnish is a medical device that received FDA 510(k) clearance on 2025-11-21. The listed applicant is Centrix, Inc.. The 510(k) number is K250714.

When did FluoroDose Varnish receive FDA 510(k) clearance?

FluoroDose Varnish received FDA 510(k) clearance on 2025-11-21, under 510(k) number K250714.

Who is the listed applicant for FluoroDose Varnish?

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

What is the FDA product code for FluoroDose Varnish?

The FDA product code for FluoroDose Varnish is LBH.

其他以 Centrix, 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。

K222459Centrix FluoroSilver Silver Diamine Fluoride 38%K152826無線電纜

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.K243777Rennou™ 漆光劑（3% / 薄荷）；Rennou™ 漆光劑（3% / 草莓）；Rennou™ 漆光劑（3% / 樱桃）；Rennou™ 漆光劑（3% / 气球糖）Theodent, LLC

官方來源

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