台灣醫療器材
許可證資料查詢
MEDCHECK許可證索引
衛署醫器輸字
許可證編號
022171
輸入器材
醫療器材許可證 / 輸入器材

“希格”愛司植體

“SIC” ace screw Implant

衛署醫器輸字第022171號
本站收錄狀態核准有效
有效日期2031 / 02 / 21
醫療器材級數第三等級

申請商為 合皓股份有限公司,收錄 21 個 UDI 型號。 以下整理許可證、規格與製造廠資料,供核對產品身分使用。

許可證資料 依公開資料欄位整理

許可證字號
衛署醫器輸字第022171號
申請商
合皓股份有限公司 (查看此申請商全部許可證)
統一編號
84100545
申請商地址
新北市三重區重新路4段97號15樓
發證日期
2011 / 02 / 21
有效日期
2031 / 02 / 21
限制項目
委託製造、輸 入
資料異動日期
2025 / 10 / 17

這類器材是什麼 骨內植體,AI 輔助整理

骨內植體就是大家常說的「人工牙根」,是一根鈦或陶瓷做的螺絲,手術時鎖進缺牙處的齒槽骨裡,等骨頭長牢後再裝上假牙。它在台灣屬於醫療器材,第3等級。

它跟假牙、牙橋差在哪

傳統固定假牙(牙橋)要把缺牙兩邊的健康牙齒磨小當支柱;活動假牙則是靠牙鉤或牙床支撐,可以拿下來。植體是直接固定在骨頭裡,不必磨旁邊的牙齒,咬合力也比較接近真牙。缺牙的處理方式不只一種,哪種合適要看骨頭條件、缺牙位置和整體口腔狀況。

一顆植體包含哪些零件

  • 植體本體:鎖進骨頭的那根螺絲,材質以鈦為主。
  • 支台齒:接在植體上方、穿出牙肉的轉接零件,之後假牙套在上面。
  • 覆蓋螺絲:手術後暫時封住植體頂端,等骨整合完成再換成支台齒。
  • 骨粉、再生膜等:骨頭不夠時可能一併使用,屬於其他分類的器材。

誰會用到它

  • 單顆缺牙,不想磨掉兩側健康牙齒的人。
  • 多顆缺牙或全口無牙,評估用多顆植體支撐固定式或活動式假牙的人。
  • 長期戴活動假牙覺得鬆動、咬不穩,想改善固定方式的人。
  • 不是每個人都能做。骨質不足、控制不好的糖尿病、長期抽菸、口腔衛生難以維持的人,風險較高,需要個別評估。

怎麼確認買到的是合法的

植體是醫師選用、手術植入的器材,民眾不會自己買,但可以確認診所使用的是有許可證的產品。包裝或標籤上會有醫療器材許可證字號,格式像「衛部醫器輸字第○○○○○○號」或「衛部醫器製字第○○○○○○號」。本站收錄 303 張有效的骨內植體許可證,其中約 79% 是進口,國內製造約 21%。

常見問題

植牙會痛嗎?

手術在局部麻醉下進行,過程中通常不會痛,術後麻藥退了會有腫脹和不適,多半可以用一般止痛藥控制。疼痛程度和手術範圍、個人體質有關,如果出現持續劇痛、發燒或傷口化膿,要盡快回診。

植牙可以用一輩子嗎?

不一定。植體本身多半能長期留在骨頭裡,但上面的假牙、支台齒會磨損,可能需要調整或更換。能不能用得久,和口腔清潔、抽菸、咬合習慣、定期回診都有關係。

植牙療程要多久?

不一定,常見是幾個月。植體植入後要等骨頭和植體長牢,這段時間依骨質條件和部位而異,之後才裝支台齒和假牙。有些情況可以縮短,有些需要先補骨,時間會拉長,由醫師評估。

植牙前一定要補骨嗎?

不一定。骨頭高度和厚度夠,就不需要補骨;骨頭不足時,直接植進去可能不穩,醫師會建議先補骨或選用較短的植體。要不要補、補多少,得看 X 光或電腦斷層的評估結果。

本段由 AI 依官方分類輔助整理,僅供認識器材之用,不構成醫療建議。使用前請以醫師指示與產品仿單為準。

UDI 標示 依 UDI 資料彙整

  • 單次使用是
  • 滅菌包裝是
  • 天然橡膠(乳膠)不含
  • DEHP不含
  • 批號有
  • 序號有
  • 製造日期有
  • 有效期限有
  • 健保特材未填

這張許可證底下有多個型號時,只要其中一款有標示,就顯示為「是」或「有」。

效能與規格

效能
詳如中文仿單核定本
規格
詳如中文仿單核定本。1.仿單、標籤變更:詳如中文仿單核定本(原100年3月16日核准之仿單、標籤核定本予以回收作廢,2.增加規格:詳如中文仿單核定本。

製造廠

製造商
SIC INVENT AG
國別
瑞士
廠址
BIRMANNSGASSE 3, 4055 BASEL, SWITZERLAND
製程
委託製造者
製造商
CPM Precision GmbH
國別
德國
廠址
Im Rott 5-10, 69493 Hirschberg, Germany
製程
Manufactured by
製造許可登錄編號
QSD16074

UDI 型號 共 21 筆

此許可證底下的 UDI 型號
基本 DI型號產品描述單次使用乳膠DEHP
03260301627664935180SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
03260909628670935184SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870498935140SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870504935141SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870511935142SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870528935150SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870535935151SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870542935152SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870559935153SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870610935170SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870627935171SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870634935172SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870658935174SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870665935175SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870672935176SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870696935178SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870702935179SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870719935180SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870733935182SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870740935183SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否
04260516870757935184SICace The allround implant with outstanding long-term clinical results Self-tapping screw design for all indications in oral implantology. SIC drill system for an atraumatic preparation of the implant site. Basic cylindrical shape with apical conical taper for easy insertion of the implant. High precision internal Hex with long guide surfaces for maximum stability of the implant-abutment connection and a innovative screw interface highly protected against overloading. Flexible and precise prosthetic components for all indications. Use of the SICace® implant can be recommended unreservedly in bone of D1 to D3 quality. 是 否 否

找的不是這個型號?

可改用包裝上的完整型號或許可證字號查詢。