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.

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,

ISO 9001:2008
ISO 13485:2003 Medical Device Quality Management System
FDA 510(K) clearance letter, No.K112305 ,K132570 ,K141183
Approved by notified body BSI (CE0086) for conformity with
European Medical Device Directive 93/42/EEC
Medical Device Registration Certificate of China
■ CFDA (I) 20142550080
■ CFDA (I) 20142550081
■ CFDA (I) 20142550105
Medical Device Registration Certificate of Taiwan
■ DOH-MD-(I)-No.004431

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