錫隆；結構；LFU 遮光、染色及釉料
K 號：K251084 · 2025-06-05
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器材摘要
zirkon; structure; LFU shades, stains and glazes is the device name listed in this FDA 510(k) record. The listed applicant is Estetic Ceram AG. It received FDA 510(k) clearance on 2025-06-05 under 510(k) number K251084. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the zirkon; structure; LFU shades, stains and glazes?
zirkon; structure; LFU shades, stains and glazes is a medical device that received FDA 510(k) clearance on 2025-06-05. The listed applicant is Estetic Ceram AG. The 510(k) number is K251084.
When did zirkon; structure; LFU shades, stains and glazes receive FDA 510(k) clearance?
zirkon; structure; LFU shades, stains and glazes received FDA 510(k) clearance on 2025-06-05, under 510(k) number K251084.
Who is the listed applicant for zirkon; structure; LFU shades, stains and glazes?
The FDA 510(k) record lists Estetic Ceram AG as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for zirkon; structure; LFU shades, stains and glazes?
The FDA product code for zirkon; structure; LFU shades, stains and glazes is EIH.
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。
相關器械（代碼：EIH）
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。
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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