Taiwan FDA registration f80838368a3eca5bd3e24a965fc07053

"TRUBYTE" Dental Hand Instrument (Non-Sterile)

TW: "楚拜" 牙科手用器械 (未滅菌)

Taiwan·Risk Class 1·MD·DENTSPLY TRUBYTE·Registered Dec 21, 2016 – Dec 21, 2021Expired

Registration details

Analysis ID: f80838368a3eca5bd3e24a965fc07053
License Form: Ministry of Health Medical Device Import No. 017321
Customs Code: DHA09401732108

Company information

Manufacturer: DENTSPLY TRUBYTE
Manufacturer Country: United States
Authorized Representative: DENTSPLY SIRONA INC., TAIWAN BRANCH (U.S.A.)

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Dental Hand Instruments (F.4565)".
Product Type (Level 1): F Dental devices
Product Type (Level 2): F4565 Hand instruments for dental use
Import Information: Imported from abroad

Dates and status

Registration Date: Dec 21, 2016
Expiry Date: Dec 21, 2021

About this record

Access comprehensive regulatory information for "TRUBYTE" Dental Hand Instrument (Non-Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number f80838368a3eca5bd3e24a965fc07053 and manufactured by DENTSPLY TRUBYTE. The authorized representative in Taiwan is DENTSPLY SIRONA INC., TAIWAN BRANCH (U.S.A.).

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.