Device Dossier

Biodentine - Hygroscopic dental cement

Device Dossier for Biodentine - Hygroscopic dental cement (Hygroscopic dental cement, Class III, sponsor Specialites Septodont). ARTG record, intended…

Intended purpose

For use in dentistry as a bioactive dentine substitute. In the crown: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): Permanent dentine restoration under composites or Inlay/Onlay; Temporary dentine-enamel restoration; Restoration of deep and/or large coronal carious lesions (sandwich technique); Restoration of cervical or radicular lesions. On the pulp: For temporary teeth (children from 2 years of age) and permanent teeth (immature or mature): Pulp capping (direct and indirect); Pulpotomy for diagnosed symptoms of reversible pulpitis and irreversible pulpitis where bleeding is controlled within 5 minutes. In the root: For permanent teeth (immature or mature): Repair of root perforations; Repair of furcation perforations; Repair of perforating internal resorptions; Repair of external resorption; Root-end filling in endodontic surgery (retrograde filling). For immature permanent teeth: Apexification.

Functional description

Mechanical and physical properties similar to sound dentine and can replace it in both the crown and the root. It can be applied directly to the tooth, without prior surface treatment of calcified tissues. It creates the optimal conditions for maintenance of pulp vitality, by providing a very tight seal on the dentine surface. It prevents postoperative sensitivity and provides longevity of restorations in vital teeth. Bioactive properties promote reactionary dentine genesis and dentine bridges.

TGA Public Summary