SMART PRINT BIO BITE: Subchronic Toxicity and Implantation
Study evaluates subchronic toxicity and implantation of SMART PRINT BIO BITE resin, essential for dental device safety.
Study evaluates subchronic toxicity and implantation of SMART PRINT BIO BITE resin, essential for dental device safety.
Complete Technical Guide: SMART PRINT BIO BITE – Toxicity and Implantation Analysis
📊 Quick Technical Summary
The SMART PRINT BIO BITE SPLINT CLEAR undergoes subchronic systemic toxicity and implantation studies, evaluating potential health risks and adverse effects after continuous exposure and local tissue response. This study follows ISO 10993-11 and ISO 10993-6 standards, ensuring the biological safety of the material for dental applications.
- Test Item: SMART PRINT BIO BITE SPLINT CLEAR
- Declared Composition: Methacrylic Monomers >45%; Oligomers <50%; Dispersant <2%; Photoinitiator <2%; Additive <.01%; Pigments <1%
- Reference Standards: ISO 10993-11:2017, ISO 10993-6:2016
- Main Application: Fabrication of occlusal splints and bruxism splints
The safety of materials used in dental procedures is a fundamental pillar for patient health and professional reputation. The SMART PRINT BIO BITE SPLINT CLEAR, a high-performance resin for the fabrication of occlusal and bruxism splints, undergoes rigorous biocompatibility tests to ensure its suitability for clinical use. This article details the subchronic systemic toxicity and implantation studies, providing an in-depth analysis of the safety of this essential material in digital dentistry.
🔬 The Science Behind: Composition and Performance
0.5 Pa·s
Viscosity
1.2 g/cm³
Density
82.2
Shore D Hardness
The SMART PRINT BIO BITE SPLINT CLEAR is a translucent resin developed for the fabrication of occlusal and bruxism splints, ensuring precision and clinical results. Its declared composition includes:
- METHACRYLIC MONOMERS >45%
- OLIGOMERS <50%
- DISPERSANT <2%
- PHOTOINITIATOR <2%
- ADDITIVE <.01%
- PIGMENTS <1%
The product's technical specifications are:
- Viscosity: 0.5 Pa·s
- Density: 1.2 g/cm³
- Shore D Hardness: 82.2
- Contour thickness must be greater than or equal to 2.5mm
To purchase the Smart Print Bio Bite Splint Clear, priced at R$ 171112, visit the SmartDent store.
📋 Toxicity and Implantation Assessment Protocol
This protocol describes the methodology for evaluating the subchronic systemic toxicity and local effects of the SMART PRINT BIO BITE SPLINT CLEAR after implantation in the subcutaneous tissue of rats.
Required Materials and Equipment:
- Test item: SMART PRINT BIO BITE SPLINT CLEAR (cylindrical, Ø2 mm x 6 mm)
- Reference item: High-density polyethylene
- Test system: Rattus norvegicus rats (Wistar strain), males and females
- Anesthetics and analgesics
- Sterile surgical material
- Anti-inflammatories
- Conventional feed and potable water
Step-by-Step Procedure:
- Step 1: Animal Preparation Animals will be randomly divided into two groups (control and test), anesthetized, and treated with analgesics. The animals' backs will be shaved.
- Step 2: Surgical Preparation After the medication takes effect, animals will be placed on a surgical table, the skin will be aseptically prepared and covered with a sterile surgical drape, exposing only the area necessary for surgery.
- Step 3: Incision and Implantation An incision will be made in the dorsal region. After inserting the material into the subcutaneous tissue, the skin will be sutured.
- Step 4: Immediate Post-Operative The wound will be cleaned and protected with a dressing. Each animal in the test group will receive 1 implantation site for the test item. Each animal in the control group will receive 1 implantation site for the reference item.
- Step 5: Post-Surgical Treatment Animals will be treated with anti-inflammatories for at least 3 days to minimize pain and the risk of surgical wound infection.
- Step 6: Observation and Clinical Evaluation Animals will be observed during the first hours of recovery after implantation and clinically evaluated weekly for signs of toxicity. Body weights will be recorded weekly.
- Step 7: Euthanasia and Sample Collection (After 3 Months) After the 3-month period, animals will be anesthetized and euthanized by exsanguination. Necropsy will be performed, and blood and organs will be collected for additional examinations.
- Step 8: Complementary Laboratory Analyses Samples will be sent to the laboratory for complete blood count, blood biochemistry, and histopathological analysis of major organs (liver, spleen, kidney, adrenal, lung, heart, brain, muscle, lymph node, testis/ovary, femur, and implantation sites - skin). Liver, kidney, spleen, heart, and adrenal will be weighed to calculate the relative organ weight.
⚠️ Points of Attention:
- The evaluation of the mechanical or functional performance of the material is not part of the objective of this test.
- Animal integrity and welfare are ensured by current standards and legislation.
- Room temperature will be maintained between 19 and 25°C, relative humidity between 30 and 70%, and a 12/12 hour photoperiod.
✅ Conclusion and Expert Opinion
The conduct of subchronic systemic toxicity and implantation studies, in accordance with the rigorous ISO 10993-11 and ISO 10993-6 standards, demonstrates SmartDent's commitment to the safety and biocompatibility of the SMART PRINT BIO BITE SPLINT CLEAR. These tests are fundamental to ensure that the material not only meets performance expectations but, above all, protects patient health. Compliance with Good Laboratory Practices (GLP) and the expertise of laboratories such as Medlab reinforce the reliability of the results, allowing dental surgeons to use this resin with complete peace of mind in their clinical practices.
💡 Protect Your Clinical Reputation
Use certified materials and follow protocols validated by specialists. Invest in quality digital dentistry. Discover the Smart Print Bio Bite Splint Clear and ensure safety and effectiveness in your occlusal and bruxism splints.
Buy Smart Print Bio Bite Splint Clear NowPerguntas Frequentes
What is the subchronic systemic toxicity study?
The subchronic systemic toxicity study evaluates possible health risks and adverse effects caused by repeated or continuous exposure to a substance. It provides information on systemic and target organ toxic effects, serving as a basis for estimating the safety of the substance. For the SMART PRINT BIO BITE SPLINT CLEAR, this study was conducted in rats for 3 months, following ISO 10993-11:2017.
What is the objective of the implantation test for SMART PRINT BIO BITE SPLINT CLEAR?
The implantation test consists of evaluating local effects after implanting a material in an animal species. The objective is to characterize the history and evolution of the tissue response after the implantation of a medical device, evaluating its biological safety. For the SMART PRINT BIO BITE SPLINT CLEAR, the material was implanted in the subcutaneous tissue of rats, according to ISO 10993-6:2016.
Which biocompatibility standards does SMART PRINT BIO BITE SPLINT CLEAR meet?
The SMART PRINT BIO BITE SPLINT CLEAR is evaluated according to ISO 10993-11: Biological evaluation of medical devices - Tests for systemic toxicity (2017) and ISO 10993-6: Biological evaluation of medical devices – Tests for local effects after implantation (2016). Additionally, the Maximized Skin Sensitization study follows ISO 10993-10:2021.
What is the declared composition of SMART PRINT BIO BITE SPLINT CLEAR?
The declared composition of SMART PRINT BIO BITE SPLINT CLEAR includes METHACRYLIC MONOMERS >45%, OLIGOMERS <50%, DISPERSANT <2%, PHOTOINITIATOR <2%, ADDITIVE <.01%, and PIGMENTS <1%. This formulation is designed to ensure the mechanical properties and biocompatibility necessary for the fabrication of occlusal and bruxism splints.
What are the technical specifications of SMART PRINT BIO BITE SPLINT CLEAR?
The technical specifications of SMART PRINT BIO BITE SPLINT CLEAR are: Viscosity of 0.5 Pa·s, Density of 1.2 g/cm³, and Shore D Hardness of 82.2. The contour thickness must be greater than or equal to 2.5mm. These characteristics ensure the precision and durability of the fabricated splints.
Where can I purchase SMART PRINT BIO BITE SPLINT CLEAR?
The SMART PRINT BIO BITE SPLINT CLEAR can be purchased from the SmartDent online store. The product price is R$ 171112. SmartDent is an official distributor and offers complete solutions for digital dentistry, ensuring high-quality and certified products.
Who performed the safety studies for SMART PRINT BIO BITE SPLINT CLEAR?
The subchronic systemic toxicity and implantation studies, as well as the maximized skin sensitization study, were conducted by MEDLAB PRODUTOS DIAGNÓSTICOS LTDA., a laboratory with GLP (Good Laboratory Practice) recognition under REBLAS number BPL 0041. The study director was Andrea da Costa, M.Sc, PhD, CRBio 072416.
What is the importance of an occlusal splint material being biocompatible?
Biocompatibility is crucial for materials in prolonged contact with biological tissues, such as occlusal splints. A biocompatible material minimizes the risk of adverse reactions, inflammation, systemic or local toxicity, and sensitization. The SMART PRINT BIO BITE SPLINT CLEAR, by undergoing rigorous tests according to ISO standards, ensures patient safety and treatment longevity.
Does the toxicity study evaluate the mechanical performance of the material?
No, the subchronic systemic toxicity and implantation study does not aim to evaluate the mechanical or functional performance of the material. Its primary focus is biological safety, i.e., the absence of systemic or local adverse effects. Mechanical properties are evaluated by other specific tests, whose data are presented separately, such as the Shore D Hardness of 82.2.
Why does SmartDent invest in biocompatibility tests for its resins?
SmartDent, as a distributor and developer of solutions in digital dentistry, prioritizes the safety and quality of its products. Investing in rigorous biocompatibility tests, such as those performed for the SMART PRINT BIO BITE SPLINT CLEAR, ensures that the resins meet the highest international standards, protecting patient health and offering dentists and dental laboratories reliable and certified materials.