Clinical Research Directory

Inclusion Criteria: * Willing and able to sign and date the informed consent form. * In need of an implant in position 16 to 26 or 36 to 46 (2nd and 3rd molars are excluded), and each subject can only receive one implant. * Deemed by the PI/Subinvestigator as likely to present with an initially stable implant situation. * A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture. * An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally. Exemption: If the planned implant is in the first molar position, an edentulous space is accepted distally Exclusion Criteria: * Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation. * Unlikely to be able to comply with clinical investigation procedures according to PI's/Subinvestigator's judgement. * Unable or unwilling to return for follow-up visits for a period of 5 years. * Severe non-compliance to CIP as judged by the PI/Subinvestigator and/or Dentsply Sirona. * Known allergy or hypersensitivity to titanium and/or stainless steel. * Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease. * Uncontrolled para-functional habits, e.g. bruxism. * Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant area (gap filling at immediate placement and soft tissue grafting are allowed). * Systemic or local disease or condition that would compromise post-operative healing and/ or osseointegration. * Immunosuppression, use of corticosteroids, prior or current use of oral or intravenous bisphosphonate, or any other medication such as anti-resorptive therapy or monoclonal antibodies that could compromise post-operative healing and/or osseointegration. * Any other condition that would make the subject unsuitable for participation, including but not limited to: * History of radiation therapy in the head and neck region. * History of chemotherapy within 5 years prior to surgery. * Present alcohol and/or drug abuse. * Ongoing psychiatric illness. * Current smoking/use of tobacco, including e-cigarettes /Not applicable for UK). * Any ongoing disease that would make the subject unsuitable for participation, including but not limited to: * Recent myocardial infarction (\< 3 months\*). * Recent cerebrovascular accident (\< 3 months\*). * Recent cardiac-valvular prosthesis placement (\< 3 months\*). * Hemorrhagic diathesis. * Severe liver dysfunction. * Known or suspected current malignancy. * Uncontrolled diabetes mellitus (as reported by the subject). * Florid infection. * Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local requirements). * Previous enrolment in the present clinical investigation. * Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona personnel and the clinical investigation site). * Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last 6 months that may interfere with the present clinical investigation. '\* \< 3 months is a strict exclusion criterion. After 3 month it is up to the investigator to judge whether the subject is considered suitable for participation or not.