Biocompatibility of Smart Dent Resins — ISO 10993 Reports and Safe Clinical Use
Smart Dent resins have GLP biocompatibility reports issued by Groupe ICARE (Switzerland). Understand what ISO 10993 means for the clinical safety of your patients.
Smart Dent resins have GLP biocompatibility reports issued by Groupe ICARE (Switzerland). Understand what ISO 10993 means for the clinical safety of your patients.
Biocompatibility of Smart Dent Resins
What is ISO 10993?
ISO 10993 is the family of international standards that defines biocompatibility requirements for medical devices. It evaluates cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity.
Tests performed by Smart Dent
The reports were issued by Groupe ICARE (France and Switzerland), a GLP (Good Laboratory Practice) laboratory recognized by the FDA and European regulatory authorities.
Main product: Smart Print Bio Vitality
- Cytotoxicity test (ISO 10993-5): APPROVED
- Sensitization test (ISO 10993-10): APPROVED
- Irritation test (ISO 10993-23): APPROVED
- Aqueous and solvent extract: both within safe limits
The "Bio" prefix in Smart Dent resins
Resins with names starting with "Smart Print Bio" (Bio Vitality, Bio Clear Guide, Bio Denture, Bio Bite Splint, Bio Temp) were specifically developed with a biocompatible formulation for long-term intraoral contact.
Clinical indications by contact level
- Transient mucosal contact: Smart Print Bio Clear Guide (surgical guides)
- Permanent intraoral contact: Smart Print Bio Vitality — FDA 510(k) K260152 Class II, approved for DEFINITIVE restorations (anterior and posterior crowns, veneers, lenses, inlays/onlays, removable and monolithic prostheses)
- Mucosa/gingiva: Smart Print Bio Denture (denture bases)
What this means for the dental surgeon
The use of resins with ISO 10993 reports legally validates the clinical indication and protects the professional in case of regulatory inquiries or documented clinical adversities.
Perguntas Frequentes
What is the ISO 10993 standard and why is it important for dental resins?
ISO 10993 is the family of international standards that defines biocompatibility requirements for medical devices, evaluating cytotoxicity, sensitization, irritation, systemic toxicity, and genotoxicity. It is important because it ensures that the resin is safe for contact with biological tissues.
What biocompatibility tests did Smart Dent perform on Smart Print Bio Vitality resin and what were the results?
Cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-23) tests were performed, all approved. Both the aqueous and solvent extracts were within safe limits.
Who issued the biocompatibility reports for Smart Dent resins?
The reports were issued by Groupe ICARE (France and Switzerland), a GLP (Good Laboratory Practice) laboratory recognized by the FDA and European regulatory authorities.
What does the 'Bio' prefix mean in Smart Dent resins?
Resins with names starting with 'Smart Print Bio' (such as Bio Vitality, Bio Clear Guide, Bio Denture, Bio Bite Splint, and Bio Temp) were developed with a specific biocompatible formulation for long-term intraoral contact.
Does Smart Print Bio Vitality resin have international regulatory approval?
Yes, Smart Print Bio Vitality has FDA 510(k) K260152 clearance, being a resin for definitive restorations with biocompatibility proven by ISO 10993 reports.