許可證編號033425
“希格”錐植體
SICtapered screw Implant system
申請商為 合皓股份有限公司,收錄 20 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
- 衛部醫器輸字第033425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
- 2020 / 04 / 03
- 有效日期
- 2030 / 04 / 03
- 限制項目
- 委託製造、輸 入
- 資料異動日期
- 2025 / 06 / 25
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
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 20 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 03260916628862 | 935389 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 03261206629253 | 935371 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 03270203629544 | 935387 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 03270303629623 | 935381 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876193 | 935372 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876209 | 935373 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876216 | 935374 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876223 | 935375 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876230 | 935377 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876247 | 935378 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876254 | 935379 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876261 | 935380 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876285 | 935383 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876292 | 935384 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876308 | 935385 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876315 | 935386 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876346 | 935390 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876353 | 935391 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516876360 | 935392 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 是 | 否 | 否 |
| 04260516878377 | 935393 | SICTapered (1) SICtissue concept-Crestal tissue preservation Decompression zone for crestal hard tissue pres and platform switching for increased biological and easy prosthetic handling (2) SIC multi tapered design-Optimal primary stability with full vertical insertion control Moderately tapered core in the middle and steeply tapered core in the lower part on the implant results in: • Flexible vertical insertion level maintaining and securing optimal primary stability • Deeper initial placement for easier insertion (3) SIC apical stabilising geometry Apical flute design, with great cutting performance with great cutting performance delivers solid implant stability." | 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。