氟化膠漆（A型，C型）
K 號：K253052 · 2026-06-11
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器材摘要
Fluoride Varnish (Type A,Type C) is the device name listed in this FDA 510(k) record. The listed applicant is Nagy Oral Technology Qinhuangdao Co., Ltd.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253052. 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 Fluoride Varnish (Type A,Type C)?
Fluoride Varnish (Type A,Type C) is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Nagy Oral Technology Qinhuangdao Co., Ltd.. The 510(k) number is K253052.
When did Fluoride Varnish (Type A,Type C) receive FDA 510(k) clearance?
Fluoride Varnish (Type A,Type C) received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253052.
Who is the listed applicant for Fluoride Varnish (Type A,Type C)?
The FDA 510(k) record lists Nagy Oral Technology Qinhuangdao Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Fluoride Varnish (Type A,Type C)?
The FDA product code for Fluoride Varnish (Type A,Type C) is LBH.
相關臨床試驗
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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. KGK252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404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.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
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。
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