Biodentine - Hygroscopic dental cement
Access comprehensive regulatory information for Biodentine - Hygroscopic dental cement in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class III is sponsored by Specialites Septodont Pty Ltd, manufactured by Septodont in France. The device registration started on December 06, 2011.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.