SMART PRINT BIO BITE SPLINT CLEAR: GLP ISO 10993
Explore the biocompatibility of SMART PRINT BIO BITE SPLINT CLEAR, validated by an ISO 10993 study.
Explore the biocompatibility of SMART PRINT BIO BITE SPLINT CLEAR, validated by an ISO 10993 study.
SMART PRINT BIO BITE SPLINT CLEAR: Biocompatibility and ISO 10993 Certification
📊 Quick Technical Summary
The SMART PRINT BIO BITE SPLINT CLEAR was evaluated for its potential for skin sensitization, according to the ISO 10993-10:2021 standard. The study, conducted under Good Laboratory Practice (GLP) principles, concluded that the material is non-sensitizing, ensuring safety for dental applications involving contact with biological tissues.
- Product Evaluated: SMART PRINT BIO BITE SPLINT CLEAR
- Methodology: ISO 10993-10:2021 (Skin Sensitization)
- Result: Non-Sensitizing
- Laboratory: Medlab Produtos Diagnósticos Ltda.
The safety and biocompatibility of materials used in digital dentistry are fundamental aspects for clinical practice. The certification of products such as the SMART PRINT BIO BITE SPLINT CLEAR, a 3D resin for fabricating occlusal splints and bruxism appliances, attests to compliance with rigorous international standards, providing confidence to dentists, prosthetists, and technicians.
🏆 Authority and Scientific Compliance
🔬 What Was Evaluated: Scope of the Study
The study focused on evaluating the skin sensitization of the SMART PRINT BIO BITE SPLINT CLEAR. This is a crucial criterion for materials that will have prolonged contact with biological tissues, such as occlusal splints and bruxism appliances. Skin sensitization is a delayed allergic response that can manifest after repeated exposures to the material.
The evaluated product, SMART PRINT BIO BITE SPLINT CLEAR (lot PBSF 007/24, manufactured Feb/2024, valid until Feb/2026), is a medical device with the following characteristics:
- Color: Translucent
- Declared Composition: Methacrylate Monomers >45%; Oligomers <50%; Dispersant <2%; Photo Initiator <2%; Additive <.01%; Pigments <1%
- Physical State: Solid
- Dimensions: 50x50x1.2mm
- Weight: 3.5g
📋 Skin Sensitization Evaluation Protocol (ISO 10993-10:2021)
📋 Maximized Skin Sensitization Study for SMART PRINT BIO BITE SPLINT CLEAR
This protocol details the methodology used to evaluate the sensitizing potential of the SMART PRINT BIO BITE SPLINT CLEAR material, according to ISO 10993-10:2021.
Required Materials and Equipment:
- SMART PRINT BIO BITE SPLINT CLEAR (test sample)
- 0.9% sodium chloride solution (polar vehicle)
- Cottonseed oil (non-polar vehicle)
- Freund's Complete Adjuvant (FCA)
- 10% Sodium Lauryl Sulfate (SDS)
- Guinea pigs (Cavia porcellus, Dunkin-Hartley strain)
- Syringes, sterile needles, gauze, hypoallergenic tape, micropore
- Electronic balance, clippers, incubator
- Commercial feed and filtered water for the animals
Step-by-Step Procedure:
- Step 1: Extract Preparation The test sample was extracted at 50°C for 72 hours in an incubator, using two vehicles: 0.9% sodium chloride solution (polar) and cottonseed oil (non-polar), at a ratio of 3 cm² of sample to 1 mL of vehicle. Extracts were used within 24 hours of preparation.
- Step 2: Animal Preparation Young, healthy guinea pigs (300-500g) were acclimatized for 5 days. Hair removal from the scapular region was performed approximately 24 hours before each application.
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Step 3: First Induction (Day 0)
Each animal received three pairs of intradermal injections (0.1 mL each) in the scapular region.
- Test Group: Injection 1 (1:1 v/v mixture of FCA + vehicle), Injection 2 (undiluted extract), Injection 3 (undiluted extract in 1:1 proportion with Injection 1 solution).
- Control Group: Injection 1 (1:1 v/v mixture of FCA + vehicle), Injection 2 (undiluted vehicle), Injection 3 (vehicle in 1:1 proportion with Injection 1 solution).
- Step 4: Area Pre-treatment (Day 6) The scapular area was pre-treated with 10% SDS massage to create local irritation, approximately 24 hours before the second induction.
- Step 5: Second Induction (Day 7) Topical applications of filter paper soaked in 0.5 mL (0.25 mL on each side) of the sample extract (experimental group) or 0.5 mL of cottonseed oil (control group) in the scapular region. Occlusive dressings remained for 48 hours.
- Step 6: Rest Period After the second induction, there was a 14-day rest period.
- Step 7: Challenge Period (Day 21) Cotton dressings soaked in 0.5 mL of undiluted sample extract were applied topically to the flank region (control and experimental groups). The occlusive dressing was maintained for 24 hours.
- Step 8: Evaluation of Skin Reactions Approximately 24 and 48 hours after removal of the challenge dressing (48 and 72 hours after challenge exposure), skin reactions (erythema and edema) were evaluated according to the Magnusson and Kligman scale.
- Step 9: Acceptance Criteria The material would be classified as sensitizing if: a) 30% or more of the tested animals showed a positive response (grade ≥1) at 48 and/or 72 hours, in the absence of similar results in the control group; or b) a positive reaction presented at 48 hours persisted at 72 hours in at least one animal, in the absence of similar results in the control group.
⚠️ Points of Attention:
- The maximized method aims to increase the sensitivity of the test to identify potential sensitizers.
- Previous evidence analysis was performed to ensure animal welfare, avoiding unnecessary testing on corrosive or severely irritating substances.
- The study was conducted without significant deviations from the original plan, with a minor amendment that did not impact the integrity of the results.
Results of Skin Sensitization Evaluation
The study results showed that no erythema and edema reactions were observed in the test group animals, for both polar and non-polar extracts, after the challenge evaluation. All animals showed weight gain at the end of the experimental period, indicating the absence of significant systemic toxicity.
| Group | 48 hours | 72 hours | Status |
|---|---|---|---|
| Test Group (10 animals) | 0% | 0% | ✅ Non-Reactive |
| Control Group (5 animals) | 0% | 0% | ✅ Non-Reactive |
| Group | 48 hours | 72 hours | Status |
|---|---|---|---|
| Test Group (10 animals) | 0% | 0% | ✅ Non-Reactive |
| Control Group (5 animals) | 0% | 0% | ✅ Non-Reactive |
Based on these results, the SMART PRINT BIO BITE SPLINT CLEAR was classified as non-sensitizing according to the adopted methodology.
✅ Conclusion and Clinical Relevance
"According to the methodology adopted for the study, the test item SMART PRINT BIO BITE SPLINT CLEAR was considered non-sensitizing."
— Andrea da Costa, M.Sc, PhD, Director of in vitro Toxicological Studies, Medlab Produtos Diagnósticos Ltda
For the dental surgeon, prosthetist, and technician, the non-sensitization certification of the SMART PRINT BIO BITE SPLINT CLEAR is a crucial indicator of safety. It means that the material has a low potential to induce allergic reactions in patients, even after repeated or prolonged contact with the oral mucosa. This is particularly important for devices such as occlusal splints and bruxism appliances, which are used for long periods.
Compliance with ISO 10993 standards and Good Laboratory Practice (GLP) principles confers high reliability and validity to the certification. Professionals can use the SMART PRINT BIO BITE SPLINT CLEAR with the assurance that the material has been rigorously tested for its biocompatibility, minimizing risks of adverse reactions and contributing to patient safety and treatment quality.
💡 Protect Your Clinical Reputation
Use certified materials and follow protocols validated by specialists. Invest in quality digital dentistry to ensure the safety and well-being of your patients.
To purchase the SMART PRINT BIO BITE SPLINT CLEAR and other biocompatible 3D resins, visit the Smart Dent store.
The SMART PRINT BIO BITE SPLINT CLEAR is a resin for fabricating occlusal splints and bruxism appliances, ensuring greater precision and extraordinary results. Its technical specifications include:
- 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
For more details and purchase, visit: https://loja.smartdent.com.br/bite-splint-clear. Price: R$ 171112.
Perguntas Frequentes
What does ISO 10993-10 certification mean for SMART PRINT BIO BITE SPLINT CLEAR?
The ISO 10993-10:2021 certification attests that the SMART PRINT BIO BITE SPLINT CLEAR was evaluated for its potential to cause skin sensitization and was deemed non-sensitizing. This means that the material has a low risk of inducing allergic reactions in patients, which is fundamental for medical devices that come into contact with biological tissues, such as occlusal splints.
What is the importance of a material being 'non-sensitizing' in dentistry?
A 'non-sensitizing' material is crucial in dentistry to avoid allergic reactions in patients. Skin sensitization can lead to discomfort, inflammation, and the need to remove or replace the device. The certification of SMART PRINT BIO BITE SPLINT CLEAR as non-sensitizing ensures greater safety and predictability in treatments with occlusal splints and bruxism appliances.
Where was the sensitization study of SMART PRINT BIO BITE SPLINT CLEAR conducted?
The study was conducted at Medlab Produtos Diagnósticos Ltda. laboratory, located in São Paulo, SP, Brazil. This laboratory is recognized by the Brazilian Network of Analytical Laboratories in Health (REBLAS) and operates in compliance with the Good Laboratory Practice (GLP) principles established by INMETRO and OECD, ensuring the credibility of the results.
What were the criteria for considering SMART PRINT BIO BITE SPLINT CLEAR as non-sensitizing?
The material was considered non-sensitizing because, after the challenge period, less than 30% of the tested animals showed positive reactions (erythema or edema of grade ≥1) at 48 and 72 hours, and there were no persistent positive reactions at 72 hours in any animal, in the absence of similar results in the control group. Tests were performed with polar and non-polar extracts of the material.
What are the technical specifications of SMART PRINT BIO BITE SPLINT CLEAR?
The SMART PRINT BIO BITE SPLINT CLEAR has the following specifications: Viscosity of 0.5 Pa·s, Density of 1.2 g/cm³, Shore D Hardness of 82.2. Additionally, the contour thickness for applications must be greater than or equal to 2.5mm. Its composition includes methacrylate monomers, oligomers, dispersant, photo initiator, additive, and pigments.
How does compliance with Good Laboratory Practices (GLP) affect the validity of the certification?
Compliance with Good Laboratory Practices (GLP), as per NIT-DICLA-035 (INMETRO) and OECD GLP, ensures that the study was planned, executed, monitored, recorded, and reported in a systematic and controlled manner. This guarantees the quality, integrity, and reliability of the generated data, making the certification of SMART PRINT BIO BITE SPLINT CLEAR scientifically valid and internationally recognized.
What is the Magnusson and Kligman scale used in the evaluation?
The Magnusson and Kligman scale is a classification system used to evaluate the intensity of skin reactions, such as erythema (redness) and edema (swelling), in sensitization studies. Reactions classified with a grade ≥1 are considered positive, indicating some visible alteration. In the SMART PRINT BIO BITE SPLINT CLEAR study, no positive reactions were observed on this scale.
What is the main clinical application of SMART PRINT BIO BITE SPLINT CLEAR?
The SMART PRINT BIO BITE SPLINT CLEAR is a resin for dental 3D printing developed for the fabrication of occlusal splints and bruxism appliances. Its biocompatibility and mechanical properties are optimized to ensure comfort and effectiveness in the treatment of temporomandibular disorders and bruxism.
Where can I purchase SMART PRINT BIO BITE SPLINT CLEAR and what is its price?
The SMART PRINT BIO BITE SPLINT CLEAR can be purchased at the Smart Dent store. The product price is R$ 171112. It is recommended to check availability and purchase conditions directly on the website.
What other Smart Dent products are relevant for digital dentistry?
Smart Dent offers a range of products for digital dentistry, including dental 3D printers like the Rayshape Edge Mini, UV post-curing units like the ShapeCure D and the Asiga Cure, and various 3D resins like Smart Print Model Plus and Smart Print Bio Vitality, all developed to meet the needs of dentists and prosthetic laboratories.