Five Year Survival Study Evaluating the Genesis Dental Implant System

Subjects between the ages of 18 and 85 who require dental implants

Inclusion Criteria:

• Subject must be between 18 and 85 years old, inclusive, and have passed growth maximum at the time of implant placement
• Subject must be willing to sign the informed consent document and adhere to study procedures.
• Subject must have one or more natural teeth missing or about to be extracted.
• Subject must fulfill all the accepted medical and dental requirements for treatment with dental implants.
• Subject must desire treatment with dental implants.

Exclusion Criteria:

• Subject refuses to sign the informed consent document.
• Subject's treatment success by both clinical and esthetic measures may be compromised by the restricted range of product available for the study.
• The treatment plan to use the range of products available is not in the best interests of the subject. Please see Section 1.2.1 for restrictions on product availability.
• The implant site(s) had a previously failed implant.
• Subject cannot be treated within the restrictions of the treatment plan laid out in Section 5. In addition, please see Section 1.2.1 for restrictions on product availability.
• Subject with alveolar ridge dimensions that are not sufficient to accommodate and sustain proper implant placement.
• Subject is not communicable in an understandable language.
• Current Alcohol or Drug Abuse (within previous 12 months) as noted in the subject's chart.
• Women who are pregnant at time of enrollment in to the study.
• Subject with out of control metabolic disease.
• Subject who have been on chemotherapy or long term cortisone use (at any time).
• Subject with known allergy to titanium.
• Subject with diabetes.
• Subject with a history of autoimmune disease (e.g. documented multiple allergies, systemic lupus erythematosus, dermatomyositis, etc.) or immunosuppressive disease (e.g. human immunodeficiency virus or acquired immunodeficiency syndrome).
• Subject with epilepsy.
• Subjects with uncontrolled or severe cases of hyperthyroidism, malignancies, renal disease, liver problems, hypertension, leukemia, severe vascular heart disease, hepatitis, collagen and bone diseases, or other serious illnesses.
• Subject currently taking bisphosphonate or calcium channel blockers.
• There is reasonable doubt that the subject will comply with the recall schedule.
• There is reasonable doubt that the subject will comply with the clinicians' instructions.