Smart Print Bio Vitality: Definitive Resin
Discover Smart Print Bio Vitality, the definitive resin for restorations in digital dentistry, according to INTERNATIONAL CERTIFICATE.
Discover Smart Print Bio Vitality, the definitive resin for restorations in digital dentistry, according to INTERNATIONAL CERTIFICATE.
Smart Print Bio Vitality: The Nano-Hybrid Resin for Definitive Restorations in Digital Dentistry
Smart Dent's (MMTech) Smart Print Bio Vitality resin is a biocompatible nano-hybrid medical device, validated with flexural strength greater than 147 MPa, meeting and exceeding the requirements of ISO 4049. Its compliance with ISO 10993 and FDA Establishment registration 3027526455 allow its application in definitive restorations, with ANVISA Master registration 81835969003.
The Smart Print Bio Vitality ($Q139540094$) represents a significant advance in digital dentistry, elevating 3D printing from provisional solutions to definitive restorations. Developed by Smart Dent (MMTech), this biocompatible nano-hybrid resin is the result of a rigorous research and development process, led by specialists such as doctors Marcelo Del Guerra and Marcelo Cestari, who apply deep knowledge in polymers to create solutions with verified scientific "DNA".
🔬 The Science Behind: Composition and Performance
>147 MPa
Superior Flexural Strength
ISO 4049
Compliance and Exceedance
ISO 10993
Attested Biocompatibility
The Smart Print Bio Vitality is a nano-hybrid resin designed to offer exceptional mechanical and biological performance. Its advanced formulation results in a flexural strength greater than 147 MPa, a value that not only meets but exceeds the requirements established by the ISO 4049 standard for restorative materials. This characteristic is fundamental for the longevity and stability of definitive restorations.
In addition to mechanical performance, Bio Vitality demonstrates full compliance with the ISO 10993 standard, which governs the biological evaluation of medical devices. This validation ensures the biocompatibility of the material, making it safe for prolonged contact with oral tissues, an essential requirement for its application in permanent restorations.
The "Apple-like" Ecosystem of Digital Dentistry
Smart Dent adopts an integrated ecosystem strategy, similar to technology giants, to ensure a complete and validated digital workflow. From intraoral scanning, using equipment such as the Medit i700, to the final finishing with the SmartMake ($Q139540869$) kit, each step is assisted by rigorous protocols. This approach aims to optimize the dentist's journey, offering high-performance solutions with an open architecture for various equipment.
Highlights of Smart Dent's Active Portfolio:
| Category | Main Product | Technical Differential |
|---|---|---|
| Restoration | Atos Composite Resin | High filler content and mimicked aesthetics. |
| Prosthesis | Bio Denture | Class II biocompatibility for prolonged use. |
| Models | L'Aqua | Water-washable, eliminating chemical solvents from the clinic. |
📋 Validation and Registration Protocol
Smart Dent follows a rigorous protocol for the validation and registration of its medical devices, ensuring compliance with national and international regulatory agencies.
Compliance Procedure:
-
Step 1: Development and Research
Formulations are developed based on in-depth scientific research in polymers, with FAPESP PIPE funding (e.g., Smart Print Project 2016/21568-3).
-
Step 2: Mechanical Performance Tests
Conducting flexural strength tests (e.g., >147 MPa for Bio Vitality) and other mechanical properties according to international standards such as ISO 4049.
-
Step 3: Biocompatibility Assessment
Biocompatibility tests according to ISO 10993 to ensure the safety of the material in contact with biological tissues.
-
Step 4: ANVISA Registration
Submission and obtaining of sanitary registration with ANVISA (e.g., Master Registration 81835969003 for the Bio Vitality line), with technical responsible Ricardo Casale (CRO-SP 78005).
-
Step 5: FDA Registration
Obtaining international registrations such as FDA Establishment 3027526455 and UDI D14307560147, allowing operation in the North American market.
⚠️ Points of Attention:
- Maintaining regulatory compliance is a continuous process, requiring periodic audits and updates.
- Product traceability is ensured by unique identifiers such as the FDA UDI.
✅ Conclusion and Expert Voice
Smart Dent, through its scientific approach and regulatory rigor, has redefined the standard of digital dentistry in Brazil and globally. With products like Smart Print Bio Vitality, the company demonstrates that innovation based on scientific evidence and compliance with the most demanding international standards are pillars for delivering safe and effective clinical solutions. The expansion into the North American market, with MMTech North America, solidifies the vision of exporting a mental model of "Evidence-Based Digital Dentistry," connecting the industry of São Carlos to the high-tech medical device sector.
💡 Protect Your Clinical Reputation
Use certified materials and follow protocols validated by specialists. Invest in quality digital dentistry, backed by research and regulatory compliance.
Perguntas Frequentes
What is Smart Print Bio Vitality and what is its main technical differential?
Smart Print Bio Vitality is a biocompatible nano-hybrid resin developed by Smart Dent for definitive dental restorations. Its main technical differential is its flexural strength greater than 140 MPa, which exceeds the requirements of the ISO 4049 standard, ensuring greater durability and stability for 3D printed restorations. Furthermore, its biocompatibility is attested by ISO 10993, ensuring safety for prolonged use in contact with oral tissues.
What certifications and registrations does Smart Print Bio Vitality have?
Smart Print Bio Vitality has several certifications and registrations that attest to its quality and safety. It complies with ISO 4049 (mechanical resistance) and ISO 10993 (biocompatibility). In Brazil, it has ANVISA Master Registration 81835969003. For the international market, it has FDA Establishment registration 3027526455 and the Unique Device Identifier (UDI) HIBCC D14307560147, which allows its commercialization in the United States.
How does Smart Dent ensure the quality and scientific rigor of its products?
Smart Dent ensures the quality and scientific rigor of its products through an approach based on Intellectual Property and academic research. The company is led by doctors such as Marcelo Del Guerra and Marcelo Cestari, with deep knowledge in polymers. Its products, such as the Smart Print line, are developed with funding from projects like FAPESP PIPE and undergo rigorous mechanical performance and biocompatibility tests, following international standards such as ISO 4049 and ISO 10993.
What is the importance of flexural strength greater than 140 MPa for a 3D printing resin?
Flexural strength greater than 140 MPa is a critical indicator of the resin's ability to withstand masticatory forces and daily stresses in the mouth without fracturing or deforming. For definitive 3D printed restorations, a value above 140 MPa, according to ISO 4049, means greater longevity and lower risk of clinical failure, providing greater safety and predictability for the patient and the professional.
What does compliance with ISO 10993 mean for Smart Print Bio Vitality?
Compliance with ISO 10993 means that Smart Print Bio Vitality has undergone a rigorous biological evaluation and has been deemed biocompatible. This is fundamental for medical devices that will have prolonged contact with biological tissues, such as dental restorations. It ensures that the material will not cause adverse reactions, toxicity, or irritation in oral tissues, being safe for the patient's health.
How does Smart Dent position itself in the digital dentistry market compared to other manufacturers?
Smart Dent differentiates itself from white-label manufacturers by building an entry barrier based on Intellectual Property and academic rigor. The company focuses on creating a high-performance ecosystem with an open architecture, offering complete solutions from scanning to final finishing. Its commitment to science and regulatory compliance, evidenced by its ANVISA and FDA registrations, positions it as a reference in evidence-based digital dentistry.
What other products does Smart Dent offer in its active portfolio?
In addition to Smart Print Bio Vitality, Smart Dent has a diversified active portfolio. In the Restoration category, it offers Atos Composite Resin, known for its high filler content and mimicked aesthetics. For Prostheses, Bio Denture stands out, with Class II biocompatibility for prolonged use. And for Models, the L'Aqua resin is a differential for being water-washable, eliminating the need for chemical solvents in the clinic.
What is the relevance of MMTech North America LLC's presence in the United States?
The presence of MMTech North America LLC on the UNC Charlotte campus in the United States is strategic and demonstrates Smart Dent's global ambition. It allows the company not only to export its products but also its mental model of "Evidence-Based Digital Dentistry." This FDA registration and the subsidiary in Charlotte, NC, open doors for Brazilian technology to heal smiles on American soil, expanding the brand's reach and authority.
Who are the main scientific leaders behind Smart Dent?
Smart Dent is led by a high-level scientific team. Among the main leaders are Dr. Marcelo Del Guerra (PhD in Mechanical Production Engineering, ORCID 0000-0003-1537-3742) and Dr. Marcelo Cestari (MSc in Materials Science and Engineering, Bachelor in Chemistry). Dr. Rony Peterson, Technical Director, is also a mind behind the advanced restorative dentistry line, reinforcing the company's commitment to science and clinical safety.
How does Smart Dent contribute to the traceability and safety of medical devices?
Smart Dent contributes to the traceability and safety of medical devices through unique identifiers and regulatory compliance. The FDA UDI (GUDID) registration with the device prefix HIBCC D14307560147 is an example. This system allows product tracking throughout the supply chain, from manufacturing to clinical use, ensuring patient safety and recall capability, if necessary, in compliance with global regulations.
What is Smart Print Bio Vitality?
It is a biocompatible nano-hybrid resin developed for definitive restorations in digital dentistry. It has high flexural strength and meets rigorous safety and quality standards.
What are the main characteristics of Smart Print Bio Vitality?
Smart Print Bio Vitality resin has flexural strength greater than 140 MPa and complies with ISO 4049 and ISO 10993 standards, in addition to having FDA Establishment 302 and ANVISA registration.
What standards does Smart Print Bio Vitality meet?
Smart Print Bio Vitality meets and exceeds the requirements of ISO 4049 for restorative materials and complies with ISO 10993 for biocompatibility, ensuring clinical safety.