SMART PRINT BIO VITALITY: Pyrogen Test
Check the complete Pyrogen Test USP study for SMART PRINT BIO VITALITY, confirming its safety and quality.
Check the complete Pyrogen Test USP study for SMART PRINT BIO VITALITY, confirming its safety and quality.
SMART PRINT BIO VITALITY: Pyrogen Test
📊 Quick Technical Summary
The resin SMART PRINT BIO VITALITY, tested according to USP NF Online Chap.151 methodology (latest revision 2017), demonstrated absence of febrile response in in vivo tests. The study, conducted by Medlab Produtos Diagnósticos Ltda. laboratory, confirmed the material's compliance with pyrogen-free requirements, ensuring safety for healthcare applications.
- Item Tested: SMART PRINT BIO VITALITY
- Methodology: USP NF Online Chap.151 (2017)
- Result: Compliant (pyrogen-free)
- Application: Healthcare products
In the context of digital dentistry , the safety and biocompatibility of materials are paramount. SmartDent , a distributor and developer of digital dental solutions, presents the results of the Pyrogen in vivo Test for the Smart Print Bio Vitality 3D resin , an essential component for definitive dental restorations . This detailed study, conducted by the ICARE Medlab laboratory, validates the material's safety, reinforcing SmartDent's commitment to excellence and clinical reliability.
🔬 The Science Behind: Composition and Performance
Smart Print Bio Vitality is a nano-hybrid resin designed for definitive restorations, standing out for its advanced materials engineering. Its multimodal inorganic matrix, with particles ranging from 0.7 μm to 5 nm, provides superior mechanical and optical properties. The Bio Vitality line offers two options to meet diverse clinical needs:
- Vitality Classic: With 35% translucency, ideal for neutralizing challenging substrates and darkened backgrounds, ensuring color stability in extensive rehabilitations.
- Vitality HT (High Translucency): With 45% translucency, it mimics the depth and light transmission of natural enamel, making it the choice for thin veneers and high-performance facets.
The optimized photoinitiator technology optimizes UV curing , ensuring high geometric definition and precise interlaminar adhesion, even in 50 μm layers, preventing failures and guaranteeing color stability (Shade A2) similar to natural dentin.
Declared Composition of SMART PRINT BIO VITALITY:
- Amorphous Silica: < 5%
- Silanized Silica: > 50%
- Dispersant: < 4%
- Photoinitiator: < 4%
- Methacrylic Monomers: > 40%
- Pigments: < 0.07%
Dimensions: 50x50x1.2mm | Weight: 5g
📋 in vivo Pyrogen Test Protocol
This protocol describes the methodology used to evaluate the febrile response to the extract of SMART PRINT BIO VITALITY , according to USP NF Online Chap.151 guideline.
Required Materials and Equipment:
- Rabbits (Oryctolagus cuniculus, New Zealand strain)
- Pyrogen-free 0.9% sodium chloride solution
- Incubator (50°C)
- Depyrogenated vial, micropore, sterile gauze, syringe, and scalp vein set
- Electronic balance, laminar flow hood, water bath, temperature probe
Step-by-Step Procedure:
- Step 1: Preparation of Test Item Extract The test item ( SMART PRINT BIO VITALITY ) was extracted at 50°C for 72 hours in an incubator. The ratio used was 3 cm² of the test item to 1 mL of 0.9% sodium chloride solution, following ISO 10993-12 (2021). 350 cm² (7 units) of the test item were prepared for 116.6 mL of the solution. The extract, homogeneous, particle-free, and colorless, was used within 24 hours after preparation.
- Step 2: Animal Selection and Acclimation Three adult, healthy, nulliparous, and non-pregnant female rabbits ( Oryctolagus cuniculus , New Zealand strain) weighing over 1.5 kg were selected. The animals were acclimated to laboratory conditions for 5 days and kept in conventional cages, with commercial feed and filtered water ad libitum .
- Step 3: Pre-Test Acclimation and Baseline Temperature Measurement Animals were placed in species-specific containers and acclimated for a minimum of thirty minutes. After acclimation, the animals' control temperature (baseline temperature) was measured to determine any subsequent elevation.
- Step 4: Extract Administration The test item extract was injected intravenously into the marginal ear vein of the rabbits, according to the methodology.
- Step 5: Post-Injection Temperature Monitoring After applying the test solution, temperature was measured again at approximately 30-minute intervals, for a period of 3 hours.
- Step 6: Clinical Observation and Results Recording Animals were observed throughout the study period for the presence of clinical changes. Measured temperatures were recorded.
- Step 7: Results Evaluation The product is considered satisfactory if no rabbit shows an individual temperature increase of 0.5°C or more, above its respective control temperature.
⚠️ Points of Attention:
- Compliance with Good Laboratory Practices (GLP) is crucial for the study's validity.
- Any decrease in temperature is considered as zero for evaluation purposes.
- In case one or more rabbits show a temperature increase ≥ 0.5°C, retesting with five additional rabbits is necessary.
✅ Conclusion and Expert's Voice
“The compliance of SMART PRINT BIO VITALITY with the rigorous criteria of the USP NF Online Chap.151 Pyrogen Test is a testament to its safety and quality. This result, combined with its nano-hybrid architecture and optical versatility, positions it as a reliable choice for definitive restorations in digital dentistry , minimizing risks and optimizing clinical time.”
— Andrea da Costa, M.Sc, PhD, Director of in vitro Toxicological Studies, Medlab Produtos Diagnósticos Ltda.
💡 Protect Your Clinical Reputation
Use certified materials and follow protocols validated by specialists. Invest in quality digital dentistry and ensure safety and predictability in your procedures. Discover Smart Print Bio Vitality and elevate the standard of your restorations.
Buy Smart Print Bio Vitality NowPerguntas Frequentes
What is the Pyrogen Test and why is it important for SMART PRINT BIO VITALITY?
The Pyrogen Test is a biological assay that evaluates the presence of pyrogenic (fever-causing) substances in products. For SMART PRINT BIO VITALITY, which is a healthcare product, this test is crucial to ensure that the material will not induce a febrile or inflammatory response in the patient, guaranteeing its biocompatibility and safety for clinical use in definitive restorations. Compliance with this test is an indicator of high quality and safety.
What methodology was used in the SMART PRINT BIO VITALITY Pyrogen Test?
The Pyrogen Test for SMART PRINT BIO VITALITY was conducted following the USP NF Online Chap.151 methodology, in its latest revision from 2017. This is an internationally recognized guideline for the evaluation of pyrogens in pharmaceutical products and medical devices, ensuring the robustness and scientific validity of the results obtained by Medlab Produtos Diagnósticos Ltda. laboratory.
What were the results of the Pyrogen Test for SMART PRINT BIO VITALITY?
The results of the in vivo Pyrogen Test demonstrated that SMART PRINT BIO VITALITY is compliant with the adopted methodology. None of the three tested rabbits showed an individual temperature increase equal to or greater than 0.5°C after the injection of the material's extract. The total temperature variation recorded among the animals was only 0.8°C, confirming the absence of a febrile response and the product's safety.
What are the main components of SMART PRINT BIO VITALITY resin?
SMART PRINT BIO VITALITY is a nano-hybrid resin composed of Amorphous Silica (< 5%), Silanized Silica (> 50%), Dispersant (< 4%), Photoinitiator (< 4%), Methacrylic Monomers (> 40%), and Pigments (< 0.07%). This balanced composition, with a multimodal inorganic matrix, is fundamental for its mechanical, optical, and biocompatibility properties, making it ideal for definitive restorations.
How does SMART PRINT BIO VITALITY ensure color stability and long-term aesthetics?
SMART PRINT BIO VITALITY ensures color stability and long-term aesthetics through its nano-hybrid material architecture and an optimized photoinitiator system. The smooth surface minimizes biofilm accumulation, and optical stability with natural dentin-like fluorescence contributes to aesthetic mimicry. The Vitality photoinitiator technology optimizes UV curing, ensuring dimensional fidelity and interlaminar integrity, which prevents failures and maintains superior color (Shade A2) over time.
Does SMART PRINT BIO VITALITY have biocompatibility certifications?
Yes, SMART PRINT BIO VITALITY has proven biocompatibility through international and national certifications, including ISO 10993, ANVISA, and FDA. These certifications attest that the material is safe for contact with biological tissues and for use in medical devices, offering safety and peace of mind for both the professional and the patient in dental procedures.
What is the difference between Vitality Classic and Vitality HT (High Translucency)?
The SMART PRINT BIO VITALITY line offers two distinct optical solutions. Vitality Classic, with 35% translucency, is ideal for absolute optical control, neutralizing challenging substrates and darkened backgrounds. Vitality HT (High Translucency), with 45% translucency, is designed for superior aesthetic mimicry, reproducing the depth and light transmission of natural enamel, making it the choice for thin veneers and high-performance facets.
Where can I purchase SMART PRINT BIO VITALITY resin?
SMART PRINT BIO VITALITY resin can be purchased directly from the SmartDent online store. Visit https://loja.smartdent.com.br/resina-smart-print-bio-vitality for more information and to make your purchase. SmartDent is an official distributor and offers all the necessary technical support for product use.
What are the benefits of using SMART PRINT BIO VITALITY in definitive restorations?
The use of SMART PRINT BIO VITALITY in definitive restorations offers benefits such as superior mechanical tenacity, fracture resistance, optical stability with natural fluorescence, and a smooth surface that minimizes biofilm accumulation. Its curing precision and long-term color stability, combined with proven biocompatibility, ensure predictability and clinical excellence, optimizing working time and patient satisfaction.
How does SmartDent ensure the quality and safety of the products it distributes?
SmartDent ensures the quality and safety of the products it distributes through a rigorous selection of international manufacturers and the execution of detailed studies and tests, such as the SMART PRINT BIO VITALITY Pyrogen Test. The company acts as a national reference in complete digital dentistry workflows, with expertise in 3D resins, printing, CAD/CAM, and scanning, ensuring that only high-performance and certified solutions reach professionals.