Device Dossier

Dental implant suprastructure device, permanent

Device Dossier for Dental implant suprastructure device, permanent (Dental implant suprastructure device, permanent, Class IIb, sponsor Southern…

Intended purpose

TiBases are indicated for use with screw-retained multiple-unit abutments in the maxilla and mandible. Standard TiBases should be used when at least 75% of the TiBase can be embedded into acrylic during the pickup. When the tissue is not accommodating for Standard TiBases, Tall TiBases can be used for proper pickup. Cementable TiBases are preferred when a prosthesis is manufactured with precise pockets for cementation of a TiBase. Smart Denture Conversions’ TiBases are intended for single use. Re-use of single use devices creates a potential risk of patient or user infection and misfitting components.

TGA Public Summary