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Sign in to claim this brandMMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.
US
Last updated May 23, 2026
What MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA. makes
The company manufactures dental resin materials used for fabricating appliances, including the Smart Dent® line of products.
These products are regulated under FDA 510(k) and UDI requirements, with devices classified as Class I and Class II. The company is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does MMTECH Projetos Tecnológicos Importação e Exportação Ltda. manufacture?
MMTECH specializes in dental appliance fabrication materials, specifically resin-based products. Their primary focus is on the Smart Dent® line, which is designed for creating dental appliances. These materials fall under the category of dental resins and are used in procedures requiring custom-fitted oral devices.
Where is MMTECH Projetos Tecnológicos Importação e Exportação Ltda. based?
The company is based in the United States. This location influences its regulatory compliance, particularly under FDA guidelines, which govern the manufacturing and distribution of its dental resin products.
Which regulatory registries or databases list MMTECH’s devices?
MMTECH’s devices are listed under the FDA’s 510(k) premarket notification process and the FDA’s Unique Device Identification (UDI) system. These registries ensure traceability and compliance tracking for dental resin materials like Smart Dent®, which are classified as either Class I or Class II devices.
How are MMTECH’s dental resin devices classified under FDA regulations?
MMTECH’s dental resin devices, such as those in the Smart Dent® line, are classified as either Class I or Class II under FDA regulations. The classification depends on factors like the intended use, risk level, and potential impact on patient safety. Class I devices generally pose minimal risk, while Class II devices require special controls to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 899849957
Catalogue (21)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Smart Dent ® | SMART PRINT OCHER MODEL 500G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT UNIVERSAL MODEL SALMON 500G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT BIO CLEAR GUIDE 250GR | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT TRY-IN CASTABLE 1KG | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT BIO CLEAR GUIDE 500G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT BIO CLEAR GUIDE 1KG | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT OCHER MODEL 250GR | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT GUM MODEL COLOR PINK 250G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT L'AQUA MODEL 1KG | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT PRECISION MODEL 250G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT PRECISION MODEL 500G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT UNIVERSAL MODEL SALMON 100G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT BIO CLEAR GUIDE 100G | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT PRECISION MODEL 1KG | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT UNIVERSAL MODEL SALMON 1KG | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT L'AQUA MODEL 250g | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT OCHER MODEL 1KG | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT UNIVERSAL MODEL SALMON 250GR | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT L'AQUA MODEL 500g | FDA UDI | Class I | Active |
| Smart Dent ® | SMART PRINT TRY-IN CASTABLE 250G | FDA UDI | Class I | Active |
| Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | K260152 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. SAO CARLOS Sao Paulo · BR FEI 3027526455