FDA 510(k)

NOVA RESIN雙固化，自粘合樹脂膠泥

K 號：K213609 · 2022-08-09

申請人Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

決定日期2022-08-09

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

NOVA RESIN dual cure, self adhesive resin cement is the device name listed in this FDA 510(k) record. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. It received FDA 510(k) clearance on 2022-08-09 under 510(k) number K213609. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NOVA RESIN dual cure, self adhesive resin cement?

NOVA RESIN dual cure, self adhesive resin cement is a medical device that received FDA 510(k) clearance on 2022-08-09. The listed applicant is Imicryl Dis Malzemeleri Sanayi VE Ticaret AS. The 510(k) number is K213609.

When did NOVA RESIN dual cure, self adhesive resin cement receive FDA 510(k) clearance?

NOVA RESIN dual cure, self adhesive resin cement received FDA 510(k) clearance on 2022-08-09, under 510(k) number K213609.

Who is the listed applicant for NOVA RESIN dual cure, self adhesive resin cement?

The FDA 510(k) record lists Imicryl Dis Malzemeleri Sanayi VE Ticaret AS as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOVA RESIN dual cure, self adhesive resin cement?

The FDA product code for NOVA RESIN dual cure, self adhesive resin cement is EMA.

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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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