ZircaGlow & ZircaGlow HT 钨酸鎂
K 號：K250393 · 2025-05-12
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器材摘要
ZircaGlow & ZircaGlow HT Zirconia is the device name listed in this FDA 510(k) record. The listed applicant is United Zirconia. It received FDA 510(k) clearance on 2025-05-12 under 510(k) number K250393. 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 ZircaGlow & ZircaGlow HT Zirconia?
ZircaGlow & ZircaGlow HT Zirconia is a medical device that received FDA 510(k) clearance on 2025-05-12. The listed applicant is United Zirconia. The 510(k) number is K250393.
When did ZircaGlow & ZircaGlow HT Zirconia receive FDA 510(k) clearance?
ZircaGlow & ZircaGlow HT Zirconia received FDA 510(k) clearance on 2025-05-12, under 510(k) number K250393.
Who is the listed applicant for ZircaGlow & ZircaGlow HT Zirconia?
The FDA 510(k) record lists United Zirconia as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ZircaGlow & ZircaGlow HT Zirconia?
The FDA product code for ZircaGlow & ZircaGlow HT Zirconia is EIH.
相關臨床試驗
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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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