In Clinical Evaluation Of The Abutment Product, If The Material Of The Product Under Application Is Titanium Alloy (Ti6A14V)5 Is It Possible To Select The Product Made Of Pure Titanium (TA4) As The Predicate Device For Comparison?
2023-02-07
The predicate device refers to the product that has been approved for registration in China and are basically equivalent to the product under application in terms of basic principle, structural composition, manufacturing materials, manufacturing process, performance requirements, safety evaluation and intended use, etc. If the administrative counterpart can prove that differences between titanium alloy (Ti6A14V)-based abutment and pure titanium (TA4)- based abutment would not affect the safety and effectiveness of the product, such product can be used as the predicate device for comparison.
