FDA 510(k)

ICE陶瓷，ICE染色，Fresco

K 號：K213722 · 2022-12-14

決定日期2022-12-14

產品代碼EIH

諮詢委員會DE

決定相當於

器材摘要

ICE Ceramics, ICE Stains, Fresco is the device name listed in this FDA 510(k) record. The listed applicant is Zirkonzahn Srl. It received FDA 510(k) clearance on 2022-12-14 under 510(k) number K213722. 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 ICE Ceramics, ICE Stains, Fresco?

ICE Ceramics, ICE Stains, Fresco is a medical device that received FDA 510(k) clearance on 2022-12-14. The listed applicant is Zirkonzahn Srl. The 510(k) number is K213722.

When did ICE Ceramics, ICE Stains, Fresco receive FDA 510(k) clearance?

ICE Ceramics, ICE Stains, Fresco received FDA 510(k) clearance on 2022-12-14, under 510(k) number K213722.

Who is the listed applicant for ICE Ceramics, ICE Stains, Fresco?

The FDA 510(k) record lists Zirkonzahn Srl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ICE Ceramics, ICE Stains, Fresco?

The FDA product code for ICE Ceramics, ICE Stains, Fresco is EIH.

其他以 Zirkonzahn Srl 為申請人之記錄

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K232691Polibond K203765ZIRKONZAHN.植牙計劃器，ZIRKONZAHN.植牙計劃器實踐，CAD/CAM STL 轉換器，CAD/CAM Z-Tray K200676ABRO 1，RESITON GINGIVA，PRIME 和 THERAPON TRANSPA K190518顏色液體，維他液體 K183304Prettau, ICE, Z-White 鑫鐙質素片 K181484Tecno Med, Tecno Med 矿物, Tecno Med 矿物牙質, Tecno Med 矿物組織

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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。

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