Taiwan FDA registration d014122a60d5050015689ef66f121d2d

"Tumen" Intraoral drill bit (unsterilized)

TW: "圖門" 口內牙鑽頭(未滅菌)

Taiwan·Risk Class 1·TruAbutment Inc.;; TruAbutment Korea Co., Ltd.·Registered Apr 23, 2021 – Apr 23, 2026Expired

Registration details

Analysis ID: d014122a60d5050015689ef66f121d2d
Customs Code: DHA09402252403

Company information

Manufacturer: TruAbutment Inc.;; TruAbutment Korea Co., Ltd.
Manufacturer Country: Korea, Republic of;;United States
Authorized Representative: HYGEA TECHNOLOGY CO., LTD.

Product details

Intended Use: It is limited to the first-level identification scope of the intraoral dental drill bit (F.4130) of the classification and grading management measures for medical equipment.
Product Type (Level 1): F Dentistry
Product Type (Level 2): F.4130 Internal Dental Drill Bits
Import Information: Contract manufacturing;; input

Dates and status

Registration Date: Apr 23, 2021
Expiry Date: Apr 23, 2026

About this record

Access comprehensive regulatory information for "Tumen" Intraoral drill bit (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d014122a60d5050015689ef66f121d2d and manufactured by TruAbutment Inc.;; TruAbutment Korea Co., Ltd.. The authorized representative in Taiwan is HYGEA TECHNOLOGY CO., LTD..

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