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
024430
輸入器材
醫療器材許可證 / 輸入器材

“敦密”陶瓷矯正牙托

“TOMY” CERAMIC BRACKET

衛署醫器輸字第024430號
本站收錄狀態核准有效
有效日期2028 / 01 / 10
醫療器材級數第二等級

申請商為 新雅貿易有限公司,收錄 44 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024430號
申請商
新雅貿易有限公司 (查看此申請商全部許可證)
統一編號
04629398
申請商地址
臺北市中正區南昌路1段147巷2弄2號1樓
發證日期
2026 / 08 / 18
有效日期
2028 / 01 / 10
限制項目
輸 入
資料異動日期
2026 / 08 / 27

這類器材是什麼 牙科矯正塑膠托架及牙套,AI 輔助整理

牙科矯正塑膠托架及牙套是矯正牙齒用的透明塑膠牙套或托架,用來把牙齒慢慢移動到正確位置。在台灣它屬於第2等級醫療器材,要有許可證才能製造或輸入。

和傳統金屬矯正器差在哪

傳統矯正器是金屬或陶瓷的小方塊,黏在牙齒上、用鋼線拉,外觀明顯,回診時由醫師調整。透明牙套是一整套客製的塑膠殼,自己按時間換下一副,外觀看不太出來,能不能用要看齒列狀況,複雜的案例不一定適合。

透明牙套是怎麼運作的

先掃描或印模,用軟體排好每一階段牙齒要移動的位置,再做出對應的一副副牙套。本站收錄 552 筆型號,其中約 83% 標示為單次使用,代表一副用完就換下一副,不是洗一洗繼續戴。

  • 每副戴的時間和天數依醫師指示,通常一天要戴滿一定時數。
  • 換下一副的時機由醫師安排,不要自己提前跳號。
  • 牙套要按醫師教的方式清潔,不要用熱水泡,會變形。
  • 戴著時不要吃東西、喝熱飲,避免染色和變形。

誰會用到它

  • 齒列擁擠、牙縫過大、輕度咬合不正,想用透明外觀矯正的人。
  • 做過矯正、想微調或維持的人。
  • 傳統矯正器不方便清潔、容易刮嘴,想換方式的人。
  • 不是每個人都適合,齒槽骨、顎骨問題或複雜咬合,可能需要其他矯正方式。

怎麼確認買到的是合法的

這類產品通常由牙醫診所引進,民眾不會自己買。重點是確認診所使用的系統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」。本站收錄的 45 張有效許可證中,35 張是進口、10 張是國內製造,製造廠以美國、台灣、中國、南韓為主。

常見問題

透明牙套和隱形矯正是一樣的東西嗎?

大致上指同一類產品,正式名稱是牙科矯正塑膠托架及牙套。市面上各家系統的品名不同,但都屬於這個官方分類,選的是療程規劃和醫師經驗,不是單看名稱。

透明牙套可以自己上網買來戴嗎?

不行。這類牙套要配合醫師的診斷、掃描和療程規劃,自己買來戴可能讓牙齒移動到不對的位置,甚至傷到牙根。合法管道是由牙醫診所評估後製作。

戴透明牙套會痛嗎?

不一定。換新的一副時,牙齒被推動,通常會有幾天緊繃、痠軟的感覺,這是正常的。如果痛到無法忍受、牙齦明顯腫或牙齒鬆動,要回診讓醫師檢查。

透明牙套要戴多久?

不一定,看牙齒要移動的距離和複雜度,從幾個月到兩、三年都有可能。實際時間由醫師依進度回診評估,自己少戴、忘記換,都會讓療程拖長。

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
  • 滅菌包裝未填
  • 天然橡膠(乳膠)不含
  • DEHP不含
  • 批號有
  • 序號無
  • 製造日期無
  • 有效期限無
  • 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。註銷規格:詳如核定之中文說明書,以下空白。
標籤、說明書或包裝變更暨遺失補發、增加規格、註銷規格及:詳如核定之標籤、說明書或包裝(原102年1月22日核定之標籤、說明書或包裝予以作廢)-115.8.18。

製造廠

製造商
Tomy Inc., Yumoto Plant
國別
日本
廠址
100-1 Bessho, Joban Fujiwaramachi, Iwaki City, Fukushima, 972-8326, Japan
製造許可登錄編號
QSD6783

UDI 型號 共 44 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
04560222154050168-01Clippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154067168-01HClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154074168-02Clippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154081168-02HClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154173168-05Clippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154180168-05HClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154210168-06Clippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
04560222154227168-06HClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153296168-101LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153319168-101RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153333168-102LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153357168-102RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153371168-111LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153395168-111RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153418168-112LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153432168-112RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153456168-201LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153470168-201RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153494168-202LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153517168-202RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153531168-301LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153555168-301RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153579168-302LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153593168-302RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153616168-303LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153630168-303RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153654168-304LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153678168-304RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153692168-311LClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 是 否 否
14560222153715168-311RClippy C, which has an aesthetic ceramic body and rhodium-coated clip is a ceramic self-ligating bracket used for orthodontic treatment. 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。