Medical Device Statement

TRONOX® titanium dioxide is not suitable for Class III medical devices or human implant devices. TRONOX titanium dioxide has not been specifically designed for implantable medical devices. 510(k) premarket notification for TRONOX titanium dioxide products has not been sought by Tronox Incorporated for Class III medical device applications. Tronox Incorporated does not represent TRONOX titanium dioxide or warranty TRONOX titanium dioxide products for materials used in implantable medical devices. Tronox Incorporated TRONOX titanium dioxide has not had supporting FDA certification testing conducted for implantable medical devices. DO NOT USE TRONOX titanium dioxide for implantable medical devices used for life-sustaining or life-supporting applications in humans.