Smart Print Bio Vitality: Definitive 3D Resin YES!
Discover Smart Print Bio Vitality: the 3D resin with FDA 510(k) K260152 approval, safe and effective for precise definitive restorations.
Discover Smart Print Bio Vitality: the 3D resin with FDA 510(k) K260152 approval, safe and effective for precise definitive restorations.
Complete Technical Guide: Smart Print Bio Vitality – The FDA-Approved 3D Resin for Definitive Restorations
📊 Quick Technical Summary
Smart Print Bio Vitality is the first and only dental resin manufactured in Latin America to receive FDA 510(k) clearance number K260152 for DEFINITIVE dental restorations in the United States. This approval validates the product for a wide range of clinical applications, including crowns, veneers, definitive inlays and onlays, and definitive removable complete dentures, as per the rigorous evaluation of the Food and Drug Administration.
- Product: Smart Print Bio Vitality
- Approval: FDA 510(k) Clearance K260152
- Main Indication: Definitive Restorations
- Manufacturer: Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
Digital dentistry has transformed clinical practice, offering more precise and efficient solutions. However, regulatory validation of materials for 3D printing, especially for definitive restorations, remains a challenge. Smart Print Bio Vitality, developed by Smart Dent, achieved a significant milestone by obtaining FDA 510(k) clearance number K260152. This approval not only validates the product's safety and efficacy but also positions it as the only dental resin for definitive restorations in Latin America with such recognition, setting a new standard of quality and reliability in the market.
🏆 Authority and Scientific Compliance
🔬 The Science Behind: Composition and Performance
FDA 510(k) K260152
Approval for definitive restorations
Biocompatibility ISO 10993
GLP tests in Swiss laboratory
Broad Clinical Indication
Crowns, veneers, inlays, onlays, and definitive prostheses
Smart Print Bio Vitality is classified as Tooth Shade Resin Material (21 CFR 872.3690) and belongs to Regulatory Class II, with product codes EBF, EBI, PZY. The determination of substantial equivalence by the CDRH means that the device is considered as safe and effective as devices legally marketed prior to May 28, 1976, or reclassified devices. The product is manufactured by Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda.
| Registration Type | What it means | Do competitors have it? |
|---|---|---|
| FDA Establishment Registration | Permit for the FACTORY to exist and export to the USA. Does not evaluate the product. | Some |
| FDA 510(k) Clearance K260152 | The FDA evaluated the PRODUCT, its indications, composition, and performance — and approved it for definitive clinical use. | NONE in Latin America |
It is essential to differentiate FDA Establishment Registration, which allows export, from FDA 510(k) Clearance, which approves the product for specific clinical use. Smart Print Bio Vitality has product approval, which is a competitive and safety advantage for dentists and dental laboratories.
📋 Smart Dent Regulatory Compliance Protocol
This protocol details Smart Dent's complete regulatory status, demonstrating its commitment to compliance and the quality of medical devices.
Verification and Maintenance Procedure:
- Step 1: Maintenance of ANVISA Certification Ensure the validity of the 22 ANVISA registrations to ensure the legality of products in Brazil.
- Step 2: Activation and Renewal of FDA Establishment Registration Maintain FDA Establishment registration 3027526455 active, allowing continuous export to the USA (active until 2026).
- Step 3: Monitoring of FDA 510(k) Clearance Monitor the status of FDA 510(k) Clearance K260152, which approves Smart Print Bio Vitality for definitive restorations in the USA.
- Step 4: Completion and Validation of Biocompatibility Reports Ensure that the GLP reports of ISO 10993, related to biocompatibility (performed by ICARE laboratory, Switzerland), are completed and updated.
- Step 5: Implementation and Certification of ISO 13485:2016 Progress in the ISO 13485:2016 (APCER) certification process for quality management of medical devices, including the application of clauses 7.3 (design controls), 8.3 (non-conforming product), 8.5.2 (corrective action), and 8.5.3 (preventive action).
⚠️ Points of Attention:
- Compliance with the Quality Management System Regulation (QMSR) (21 CFR Part 820) is essential for medical devices, including requirements for registration, labeling, adverse event reporting, and good manufacturing practices.
- The Unique Device Identification System (UDI Rule) requires devices to have a unique identifier on their label and packaging, and that specific information be submitted to the Global Unique Device Identification Database (GUDID).
✅ Conclusion and Expert's Voice
“Smart Print Bio Vitality represents a significant advance in digital dentistry. The FDA approval for definitive restorations, with clearance K260152, is not just a seal of quality, but the validation of years of research and development. This guarantees dentists and dental laboratories a reliable and safe solution, backed by the world's most rigorous regulatory body. It's not marketing; it's a public document that attests to the capability of our 3D resin for long-term clinical applications.”
— Smart Dent
💡 Protect Your Clinical Reputation
Use certified materials and follow expert-validated protocols. Invest in quality digital dentistry to offer the best to your patients. Smart Dent is an official distributor of the main digital dental brands, working with international manufacturers and its own technical teams, being a national reference in complete digital dentistry workflows.
Perguntas Frequentes
What does FDA 510(k) clearance mean for Smart Print Bio Vitality?
The FDA 510(k) clearance number K260152 means that the U.S. Food and Drug Administration (FDA) has evaluated and approved Smart Print Bio Vitality for use in DEFINITIVE dental restorations. This approval is crucial as it validates the product for long-term applications, such as crowns, veneers, inlays, onlays, and definitive removable dentures, differentiating it from resins indicated only for temporaries or long-term provisional use. It is a recognition of the material's safety, efficacy, and performance.
What are the FDA-approved indications for use for Smart Print Bio Vitality?
The indications for use approved by FDA clearance K260152 for Smart Print Bio Vitality include definitive crowns (anterior and posterior), definitive veneers, definitive inlays and onlays, artificial teeth for dentures, definitive removable complete dentures, and monolithic complete and partial removable dentures. The product is approved for use in both dental offices and laboratories, offering versatility for various clinical needs.
What is the difference between FDA Establishment Registration and FDA 510(k) Clearance?
FDA Establishment Registration is a permit for the factory to exist and export products to the USA, but it does not evaluate the product itself. FDA 510(k) Clearance, on the other hand, is a specific approval of the PRODUCT, its indications, composition, and performance for clinical use. Smart Print Bio Vitality has 510(k) clearance K260152, which means the product has been rigorously evaluated and approved for definitive restorations, a level of validation that few competitors in Latin America possess.
Is Smart Print Bio Vitality biocompatible? What certifications prove this?
Yes, Smart Print Bio Vitality is biocompatible. Its biocompatibility is proven by GLP (Good Laboratory Practices) reports from ISO 10993, conducted in an independent laboratory in Switzerland (ICARE). This certification is fundamental to ensure that the material does not cause adverse reactions when in contact with biological tissues, being an essential requirement for definitive restorative materials.
How can I verify the FDA approval of Smart Print Bio Vitality?
The FDA approval of Smart Print Bio Vitality can be publicly verified. Simply access the website accessdata.fda.gov and search for clearance number K260152. This process ensures full transparency and allows professionals and patients to confirm the product's regulatory validation directly from the official source of the U.S. Food and Drug Administration.
What are the benefits of Smart Print Bio Vitality for the digital dentistry workflow?
Smart Print Bio Vitality optimizes the digital dentistry workflow by offering a validated solution for definitive restorations. Its FDA approval simplifies material selection, eliminating the need for provisional materials and reducing chair time. The versatility for definitive crowns, veneers, and prostheses, combined with regulatory reliability, allows dentists and laboratories to integrate 3D printing more safely and efficiently into their daily practices.
Does Smart Dent have other certifications besides FDA for its products?
Yes, Smart Dent has a complete regulatory stack. In addition to FDA 510(k) Clearance K260152, the company has 22 current ANVISA registrations in Brazil, active FDA Establishment 3027526455 for export to the USA, and GLP reports from ISO 10993 for biocompatibility. ISO 13485:2016 (APCER) certification for medical device quality management is in process, reinforcing the commitment to the highest standards of quality and safety.
Why is FDA approval for definitive restorations a competitive differentiator?
FDA approval for definitive restorations is a competitive differentiator because most 3D resins in the Latin American market are indicated only for temporaries or long-term provisional use. Smart Print Bio Vitality's K260152 clearance validates the product for permanent use, giving it Class II material status with broad clinical indications. This offers professionals superior regulatory and clinical safety, distinguishing Smart Dent in the digital dental resin market.
Can Smart Print Bio Vitality be used in both dental offices and laboratories?
Yes, the FDA-approved indications for use for Smart Print Bio Vitality explicitly include use in both dental offices and laboratories. This flexibility allows the material to be integrated into different work environments, supporting the production of definitive restorations directly in the office or in dental laboratories, optimizing the digital production chain.
What is Smart Dent's positioning regarding Smart Print Bio Vitality in the market?
Smart Dent positions Smart Print Bio Vitality as 'the only 3D resin for definitive restorations in Latin America approved by the American FDA for clinical use.' This positioning is reinforced by the validation of K260152 clearance, which attests to the product's capability for definitive crowns, veneers, inlays, onlays, and prostheses. The company emphasizes that this is not a marketing claim, but a fact proven by a public document from the American government.
What is Smart Print Bio Vitality?
It is a dental 3D resin for definitive restorations, being the first and only one manufactured in Latin America to receive FDA 510(k) clearance (K260152).
What are the clinical applications of Smart Print Bio Vitality?
It is approved for a wide range of applications, including definitive crowns, veneers, inlays, onlays, and complete dentures.
What is the importance of FDA 510(k) approval for Smart Print Bio Vitality?
FDA 510(k) K260152 approval validates the safety and efficacy of the resin for definitive restorations, ensuring ISO 10993 biocompatibility and regulatory compliance.