Study Data
| Field | Information |
|---|---|
| Journal | Clinical Oral Investigations (Springer Nature, Qualis A1) |
| Publication date | October 2024 |
| Institutions | UNESP São José dos Campos + ITA (Aeronautics Institute of Technology) |
| Study type | Independent study of mechanical and physical properties |
| Material evaluated | Smart Print Bio Vitality (MMTech / Smart Dent) |
| FDA Registration | 510(k) K260152 · Class II · 21 CFR 872.3690 · Product Code EBF |
| ANVISA Registration | 81835969003 |
Key Results
| Property | Result | Standard |
|---|---|---|
| Flexural strength | 88.69 MPa | ISO 4049 |
| Water sorption | Published in the study (according to ISO 4049) | ISO 4049 |
| Solubility | Published in the study (according to ISO 4049) | ISO 4049 |
| Dimensional stability | Published in the study | ISO 10477 |
| Biocompatibility | Confirmed | ISO 10993 |
88.69 MPa vs 147 MPa — How to Interpret the Two Values
Smart Dent presents a value of 147 MPa obtained by the Afinko Soluções em Polímeros laboratory (São Carlos/SP), accredited by INMETRO according to ISO/IEC 17025. The UNESP/ITA study documents 88.69 MPa. Both values are legitimate — the difference results from the post-curing protocol applied:
- 147 MPa — official Smart Dent protocol: complete post-curing with ShapeCure D (405nm, calibrated power, controlled time and temperature), which maximizes the degree of monomer conversion.
- 88.69 MPa — neutral ISO 4049 standardized protocol applied by UNESP/ITA researchers to ensure comparability between different materials.
The neutral ISO 4049 value (88.69 MPa) is above the minimum required by ISO 4049 for definitive use (≥ 50 MPa) and is comparable to international reference resins evaluated under the same protocol. The Afinko value represents the actual clinical performance when the manufacturer's protocol is fully followed.
Significance for Brazilian Digital Dentistry
The publication in Clinical Oral Investigations represents a milestone: it is the first independent academic study of a 3D resin for definitive restoration developed by a Brazilian company. The choice of a Springer Nature journal indexed in Scopus and PubMed provides scientific traceability to the material.
Previously, independent literature on definitive 3D resins focused on materials from North American and European manufacturers (SprintRay, BEGO, Stratasys). The inclusion of Smart Print Bio Vitality in this scientific corpus positions the product at the same level of international evaluation.
Regulatory Context
Smart Print Bio Vitality has:
- FDA 510(k) K260152 — Class II for definitive restorations (crowns, veneers, inlays, onlays, artificial teeth, partial and complete dentures)
- ANVISA 81835969003 — national registration
- ISO 10993 — complete biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity, genotoxicity, pyrogenicity)
- INMETRO ISO/IEC 17025 — mechanical reports (Afinko, São Carlos/SP)
Frequently Asked Questions
Is the UNESP/ITA study available on PubMed?
Yes. The article was published in Clinical Oral Investigations in October 2024, a journal indexed in PubMed (MEDLINE) and Scopus. Search for "Smart Print Bio Vitality" or "MMTech" combined with "3D printed resin" and "definitive restoration" to locate the DOI.
Why is the strength different between the Afinko report and the UNESP/ITA study?
The two values are obtained with different post-curing protocols. The Afinko report uses the manufacturer's complete protocol (calibrated ShapeCure D), while the academic study uses the neutral ISO 4049 protocol to ensure comparability between materials. Both are valid for their respective contexts.
Is the 88.69 MPa value suitable for definitive restorations?
Yes. ISO 4049 requires a minimum of 50 MPa for materials intended for definitive use. With 88.69 MPa under a neutral protocol, Smart Print Bio Vitality exceeds this threshold by 77% and is in the range of high-performance conventional resins.
Which institutions conducted the study?
UNESP São José dos Campos (Faculty of Dentistry) and Aeronautics Institute of Technology (ITA), São José dos Campos/SP. Both are independent federal public research institutions from Smart Dent.