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FDA 510(k)

Profisil 鈣鹽膠漆組合包裝 (14801)，Profisil 鈣鹽膠漆正常包裝青草味 (14802)，Profisil 鈣鹽膠漆正常包裝莓果味 (14804)，Profisil 鈣鹽膠漆正常包裝無味 (14806)，Profisil 鈣鹽膠漆樣品包裝 (14800)

K 號：K230333 · 2023-07-24

申請人Kettenbach GmbH & Co. KG
決定日期2023-07-24
產品代碼LBH
諮詢委員會DE
決定相當於

器材摘要

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) is the device name listed in this FDA 510(k) record. The listed applicant is Kettenbach GmbH & Co. KG. It received FDA 510(k) clearance on 2023-07-24 under 510(k) number K230333. 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 Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)?

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) is a medical device that received FDA 510(k) clearance on 2023-07-24. The listed applicant is Kettenbach GmbH & Co. KG. The 510(k) number is K230333.

When did Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) receive FDA 510(k) clearance?

Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) received FDA 510(k) clearance on 2023-07-24, under 510(k) number K230333.

Who is the listed applicant for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)?

FDA 510(k) 記錄將Kettenbach GmbH & Co. KG列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)?

The FDA product code for Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) is LBH.

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 Kettenbach GmbH & Co. KG 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。

K262243Profisil 免費K250267Visalys® 大量填充 1 x 4 g 傘筒 (15060)；Visalys® 大量填充 15 x 0.25 g 壳 (15062)；Visalys® 大量流動 1 x 2 g 傘筒 (15064)；Visalys® 大量流動 15 x 0.25 g 壳 (15066)；Visalys® 大量流動 入門包 (15067)；Visalys® 大量填充 入門包 (15068)K191527Visalys CemCore, Visalys Cem Core 尝試膠膠K191523視牙修復底漆K191524視牙質底漆

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. KGK253052氟化膠漆（A型，C型）Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO 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.

官方來源

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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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