Ames Test Smart Print Bio Vitality Resin (ISO 10993)
ICARE report AMES-PH-24/0562 assessed extracts of Smart Print Bio Vitality, batch PVA3 004/24, using a bacterial reverse mutation test.
ICARE report AMES-PH-24/0562 assessed extracts of Smart Print Bio Vitality, batch PVA3 004/24, using a bacterial reverse mutation test.
AMES-PH-24/0562
ICARE report AMES-PH-24/0562 assessed extracts of Smart Print Bio Vitality, batch PVA3 004/24, using a bacterial reverse mutation test. The conclusion on page 18 reports no increase in revertant colonies in the tested strains, with or without metabolic activation, under the OECD 471 assay conditions. This does not establish absence of cancer, allergy or every clinical risk. Interpret the result together with the conditions, controls and qualifications in the full report.
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Perguntas Frequentes
What is the Ames Test and why is it important for dental resins?
The Ames Test is a bacterial reverse mutation assay that evaluates a substance's potential to induce genetic changes. For dental resins, such as Smart Print Bio Vitality, it is crucial to ensure that the material does not cause DNA damage to patient cells, preventing risks of genotoxicity and carcinogenicity, as required by ISO 10993-3.
Which standards were followed for the Ames Test on Smart Print Bio Vitality?
The Ames Test for Smart Print Bio Vitality strictly followed international standards ISO 10993-3:2014, NF EN ISO 10993-3:2014, ISO 10993-12:2021, NF EN ISO 10993-12:2021, ISO/TR 10993-33:2015 and guideline OECD n°471:2020, ensuring the validity and global acceptance of the results.
Was Smart Print Bio Vitality resin tested with and without metabolic activation? What is the relevance of this?
Yes, Smart Print Bio Vitality was tested both in the absence and presence of metabolic activation (S9-mix). The absence of activation detects direct mutagens, while the presence simulates body metabolism, identifying pro-mutagens that become active after metabolization. The fact that it is non-mutagenic under both conditions reinforces its biocompatible safety.
Which bacterial strains were used in the Ames Test and why are they important?
Four strains of Salmonella typhimurium his- (TA 1535, TA 1537, TA 98, TA 100) and one strain of Escherichia coli WP2(uvrA-)(pKM101) were used. Each strain is sensitive to different types of mutations (base pair substitution, base addition/deletion), allowing a comprehensive evaluation of the mutagenic potential of Smart Print Bio Vitality resin.
What does the 'non-mutagenic' result mean for the clinical application of the resin?
The 'non-mutagenic' result means that the extracts of Smart Print Bio Vitality resin did not induce genetic changes in the tested bacteria. Clinically, this translates into a significantly reduced risk that the material will cause DNA damage to human cells, contributing to the long-term safety of patients and compliance with biocompatibility standards for medical devices.
How does Smart Print Bio Vitality differentiate itself in terms of safety compared to other resins on the market?
Smart Print Bio Vitality stands out for having its safety proven by rigorous tests such as the Ames Test, performed by an independent and accredited laboratory (Laboratoire ICARE) under GLP and ISO 10993 guidelines. This offers dentists and prosthetists additional assurance that they are using a biocompatible and safe material for their patients, an important differentiator in a market with various options.
Where can I purchase Smart Print Bio Vitality resin and get more technical information?
Smart Print Bio Vitality resin can be purchased directly from the Smart Dent online store. For additional technical information, such as physical-mechanical properties (Flexural Strength of 147 MPa, Flexural Modulus of 5490 MPa) and complete certifications, you can consult the product page or contact Smart Dent's technical support.
What are the main physical-mechanical properties of Smart Print Bio Vitality, besides biological safety?
In addition to being biocompatible and non-mutagenic, Smart Print Bio Vitality exhibits excellent physical-mechanical properties. It has a Flexural Strength of 147 MPa and a Flexural Modulus of 5490 MPa, according to ISO 4049. Its radiopacity of 1.048 mm Al and low sorption (15.15 µg/mm³) and solubility (-4.44 µg/mm³) ensure durability and dimensional stability, essential for demanding dental applications.
How does the guarantee of non-mutagenicity impact the choice of a 3D resin for 3D dental printing?
The guarantee of non-mutagenicity is a decisive factor. It ensures that the material does not pose a risk of inducing genetic mutations, which is fundamental for the long-term safety of patients, especially in devices that will have prolonged contact with tissues. Professionals who use 3D resins like Smart Print Bio Vitality can offer treatments with greater peace of mind and regulatory compliance, elevating the quality of their services in digital dentistry.
What is the importance of a GLP (Good Laboratory Practice) report for validating the safety of a dental resin?
A GLP report, such as the one issued for Smart Print Bio Vitality, certifies that the study was conducted under a rigorous quality system. This means that all procedures, from planning to execution and report issuance, were documented and controlled to ensure the reliability, integrity, and traceability of the data. For dental resins, GLP is crucial for regulatory acceptance and for professionals' confidence in product safety.