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正海生物(300653.SZ):自酸蝕粘接劑的醫療器械註冊申請獲得受理
格隆匯 07-06 16:56

格隆匯7月6日丨正海生物(300653.SZ)公佈,公司於近日收到國家藥品監督管理局下發的醫療器械註冊申請《受理通知書》產品名稱自酸蝕粘接劑,臨牀用途:產品用於光固化複合樹脂與牙釉質、牙本質的粘接。

口腔健康是人們健康生活中重要的一環,越來越受到每個人的關注隨着收入水平、消費水平和健康意識的提高,人們越來越積極主動地修復齲齒,牙科充填和粘接材料的用量越來越高,鑑於粘接修復材料在市場上被進口產品壟斷的現狀,實現粘接材料產品國產化,提高國產產品的品質,具有重要意義。

本產品為自酸蝕粘接劑,與《免於進行臨牀試驗醫療器械目錄》分類編碼17-05-02中的牙科粘接劑產品的描述相同,屬於免於臨牀試驗的產品,術後敏感發生率低,自酸蝕粘接不需考慮牙面的濕潤程度,技術敏感度低,受到臨牀醫生的廣泛使用,可以增強對牙釉質的粘接強度,並擁有良好的邊緣封閉效果。

據公司查詢瞭解到目前3M Deutschland GmbH產品Self-Etch Adhesive國械注進20163632494適用範圍為:用於牙科修復時樹脂基類的材料與牙齒的粘接KURARAY NORITAKE DENTAL INC.的產品牙科樹脂粘合劑CLEARAFIL TRI-S BOND DENTAL BONDING AGENT國械注進20163634260),適用範圍用於牙釉質和牙本質的粘結材料。上述產品目前用於齒科修復材料方面的數據暫無法準確獲取。

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