Luminesse 遮光氧化鋁
K 號：K152023 · 2016-09-15
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器材摘要
Luminesse Shaded Zirconia SZ is the device name listed in this FDA 510(k) record. The listed applicant is Talladium, Inc.. It received FDA 510(k) clearance on 2016-09-15 under 510(k) number K152023. 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 Luminesse Shaded Zirconia SZ?
Luminesse Shaded Zirconia SZ is a medical device that received FDA 510(k) clearance on 2016-09-15. The listed applicant is Talladium, Inc.. The 510(k) number is K152023.
When did Luminesse Shaded Zirconia SZ receive FDA 510(k) clearance?
Luminesse Shaded Zirconia SZ received FDA 510(k) clearance on 2016-09-15, under 510(k) number K152023.
Who is the listed applicant for Luminesse Shaded Zirconia SZ?
The FDA 510(k) record lists Talladium, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Luminesse Shaded Zirconia SZ?
The FDA product code for Luminesse Shaded Zirconia SZ is EIH.
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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
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