Clinical Research Directory

Inclusion Criteria: * Adult aged 18 years or above at time of informed consent. * Subject willing to participate in the clinical investigation and able to understand the content of the clinical investigation. * Subject willing to comply with investigational related procedures and to return for follow-up visits for a period of 5 years. * Subject has signed and dated the informed consent form. * Subjects in need of complete dentures in maxilla and mandible. * Prosthodontic Diagnostic Index (PDI) Completely edentulous classification (Class 1-3). * History of edentulism of at least 1 year. Exclusion Criteria: * Known allergy or hypersensitivity to any of the components. * Subjects with significant systemic health issues or chronic conditions (American Society of Anesthesiologists (ASA) class 3-6 ). * Known pregnancy at time of enrolment. * Subjects unlikely to comply with investigational procedures, or unlikely to come back for follow-up visits, as judged by the Investigator. * 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). * PDI Completely edentulous classification (Class 4) * Presence of severely atrophied ridge. * Presence of severe ridge undercuts. * Clinically severe Xerostomia. * Absence of hard or soft tissue pathology that precludes denture therapy. * Maxillofacial defects. * Uncontrolled pathological process in the oral cavity, as judged by the Investigator. * Participation in another clinical investigation that may interfere with the present clinical investigation.