Device Dossier
Screw endosteal dental implant, two-piece
Device Dossier for Screw endosteal dental implant, two-piece (Screw endosteal dental implant, two-piece, Class IIb, sponsor Cyber Dental Group). ARTG…
- GMDN category: Screw endosteal dental implant, two-piece
Intended purpose
The I-RES Dental Implant System comprises a range of endosseous dental implant fixtures intended for surgical placement into the maxillary or mandibular jawbone to serve as artificial tooth roots, providing stable long-term support for prosthetic restoration of missing teeth in adult patients. The implant fixtures are manufactured from titanium and are supplied sterile. They are designed to achieve primary stability upon placement and to facilitate osseointegration over time, resulting in a stable foundation for the attachment of prosthetic components including abutments and crowns. The system encompasses multiple implant designs including bone level, tissue level, narrow diameter and conical connection configurations, accommodating a range of clinical indications and patient anatomies with varying bone volume and density. The devices are intended for use by qualified dental and oral surgery professionals in a clinical setting. Each implant fixture is intended for single use in a single patient only and must not be reused.