Medical Device Manufacturer · TW , Taichung, Roc

Ttbio Corp. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 2014

Recent clearances: EVO 700 series high speed handpiece, EVOCLEAN CLEANsert Ultrasonic Insert, TTBIO EVOCLEAN Ultrasonic Scaler

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ttbio Corp. Dental ✕

6 devices

1-6 of 6

Cleared Aug 23, 2023

EVO 700 series high speed handpiece

Cleared Feb 02, 2022

EVOCLEAN CLEANsert Ultrasonic Insert

Cleared Dec 04, 2020

TTBIO EVOCLEAN Ultrasonic Scaler

Cleared Dec 11, 2019

EVO 450 series High Speed Handpieces

Cleared Feb 27, 2015

EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED...

Cleared Apr 29, 2014

ELECTRIC HANDPIECE SYSTEM