MEDCHECK許可證索引
衛部醫器輸字
許可證編號036274
許可證編號036274
輸入器材
醫療器材許可證 ／ 輸入器材
“希格”麥斯植體
SICmax screw Implant
衛部醫器輸字第036274號
本站收錄狀態核准有效
有效日期2028 / 01 / 11
醫療器材級數第三等級
申請商為 合皓股份有限公司，收錄 23 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036274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
- 2023 / 01 / 11
- 有效日期
- 2028 / 01 / 11
- 限制項目
- 委託製造、輸 入
- 資料異動日期
- 2023 / 03 / 02
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
- 詳如核定之中文說明書
- 規格
- 詳如核定之中文說明書
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 23 筆
| 基本 DI | 型號 | 產品描述 | 單次使用 | 乳膠 | DEHP |
|---|---|---|---|---|---|
| 03260204627967 | 935282 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 03260208627622 | 935288 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 03260423610629 | 935267 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 03261105629036 | 935283 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871242 | 935265 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871259 | 935266 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871273 | 935270 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871280 | 935271 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871297 | 935272 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871303 | 935273 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871310 | 935274 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871327 | 935275 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871334 | 935276 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871341 | 935277 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871358 | 935278 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871365 | 935279 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871372 | 935280 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871389 | 935281 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871419 | 935284 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871426 | 935285 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871433 | 935286 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871440 | 935287 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
| 04260516871464 | 935289 | SICmax The solution in soft bone. Implant specially designed for use in “soft bone”. It is therefore to be used preferably for bone qualities D2 to D4. Basic cylindrical shape of the implant with crestal micro thread guarantees great primary stability. As a result, the implant is also suitable for immediate implantation. Greatly rounded implant tip without a direct thread cut for use in the upper posterior region, especially with all forms of sinus lift. Integrated “platform switching” for convenient prosthetic handling. Internal precision hexagon with long parallel-walled guide surfaces for maximum stability of the implant-abutment interface and a screw connection protected against continuous loading. | 是 | 否 | 否 |
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可改用包裝上的完整型號或許可證字號查詢。