Code of Federal Regulations Title 21. Food and Drugs § 21.872.3640 Endosseous dental implant

(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;

(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;

(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;

(iv) The device must be demonstrated to be biocompatible;

(v) Sterility testing must demonstrate the sterility of the device;

(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;

(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;

(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications;  and

(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.