Home > Quality system
We apply every well-known quality control testing methods to ensure the quality of
TTBIO dental instruments.
Our tireless efforts has been recognized by numerous approvals and certificates worldwide.
TTBIO dental instruments.
Our tireless efforts has been recognized by numerous approvals and certificates worldwide.
Safety is the #1 priority in every aspect of TTBIO product design and manufacturing.
ISO13485 medical device quality system is strictly enforced throughout our daily operation,
ISO13485 medical device quality system is strictly enforced throughout our daily operation,
ISO 9001:2015
ISO 13485:2016 Medical Device Quality Management System
ISO 13485:2016 Medical Device Quality Management System
FDA 510(K) clearance letter, No.K112305 ,K132570 ,K141183 ,K190508 ,K201317 ,K210832
Approved by notified body BSI (CE2797) for conformity with
European Medical Device Regulation (EU) 2017/745
European Medical Device Regulation (EU) 2017/745
Medical Device Registration Certificate of China
■ NMPA (I) 20192170057
■ NMPA (I) 20192170057
■ NMPA (I) 20192170058
■ NMPA (I) 20192170059
Medical Device Registration Certificate of Taiwan
■ DOH-MD-(I)-No.009729
■ DOH-MD-(I)-No.009729
1.Coordinate Measuring Machine (3D)
2.Roundness Testing Machine
3.Surface & Profilemeter
4.Laser diameter measuring instrument
5.Pneumatic micrometer
6.Profile Projectors
7.Metallographic microscope
2.Roundness Testing Machine
3.Surface & Profilemeter
4.Laser diameter measuring instrument
5.Pneumatic micrometer
6.Profile Projectors
7.Metallographic microscope
