Device Dossier

Dental implant suprastructure device, permanent

Device Dossier for Dental implant suprastructure device, permanent (Dental implant suprastructure device, permanent, Class IIb, sponsor ZimVie). ARTG…

Intended purpose

BellaTek Express and Flex Abutments are intended for use as accessories to endosseous dental implants to support a prosthetic device in a partially or completely edentulous patient. A Dental Abutment is intended for use to support single and multiple tooth prosthesis, in the mandible or maxilla. The prosthesis can be screw retained or cement retained. All digitally designed superstructures and/or hybrid abutment crowns for use with BellaTek Express or BellaTek Flex abutments are intended to be sent to a Biomet 3i validated milling center for manufacture.

TGA Public Summary