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Sign in to claim this brandMICERIUM SPA
US
Last updated May 23, 2026
What MICERIUM SPA makes
Micerium SpA manufactures dental materials and tools for restorative and orthodontic procedures, including temporary orthodontic retainers, dental composite resins, and bonding agents for dentine. Their portfolio also includes professional abrasive materials for tooth preparation, reusable application tools, and single-use cannulas for material injection. Additional offerings comprise dental acrylic resins and abrasive disks designed for precision dental treatments.
The company’s devices are regulated under FDA’s UDI system, with classifications spanning Class I and Class II. Products are listed in the FDA’s Unique Device Identifier database, ensuring compliance with U.S. medical device regulations. The manufacturer is based in the United States.
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 Micerium SpA primarily manufacture?
Micerium SpA specializes in dental materials and tools used in restorative and orthodontic treatments. Their portfolio includes temporary orthodontic retainers, dental composite resins, bonding agents for dentine, professional abrasive materials for tooth preparation, reusable application tools, single-use injection cannulas, dental acrylic resins, and abrasive disks. These products are designed to support precision dental procedures.
Where is Micerium SpA based, and how does this affect their regulatory compliance?
Micerium SpA is based in the United States, which means their devices must comply with U.S. medical device regulations. Their products are listed in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and regulatory transparency. This system helps track devices throughout their lifecycle, including manufacturing, distribution, and use.
Which regulatory registries or databases list Micerium SpA’s devices?
Micerium SpA’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry is part of the U.S. regulatory framework for medical devices, ensuring that each product has a unique identifier for tracking compliance, recalls, and post-market surveillance. Listing in this database is required for devices marketed in the U.S.
How are Micerium SpA’s devices classified under U.S. regulations?
Micerium SpA’s devices fall under FDA classifications of Class I and Class II. Class I devices generally pose minimal risk and may require general controls for regulation, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway and oversight required for each product.
Why are some of Micerium SpA’s devices listed as single-use while others are reusable?
The distinction between single-use and reusable devices depends on their intended use, risk level, and sterilization feasibility. Single-use items like abrasive disks or injection cannulas are designed for one-time use to minimize infection risks and ensure sterility. Reusable tools, such as application instruments, are engineered to withstand sterilization processes, reducing waste and cost while maintaining safety standards for repeated use in clinical settings.
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
- 436661136
Catalogue (679)
Page 5 of 14| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ena Bond ® | COSM300A2 | FDA UDI | Class II | Active |
| Temp Silicon Brush | SS1 | FDA UDI | Class I | Active |
| Amcop Bioactivator | BIO-F2HM | FDA UDI | Class I | Active |
| Temp Silicon Brush | TPENMC | FDA UDI | Class I | Active |
| Amcop Bioactivator | BC1-DTMH | FDA UDI | Class I | Active |
| Ena Shiny | ESSMS | EUDAMEDFDA UDI | Class I | Active |
| Ena Tender ® | ETPL | EUDAMEDFDA UDI | Class II | Active |
| Ena HRI ® | EHRTUD6 | EUDAMEDFDA UDI | Class II | Active |
| Ena HFO ® | EHFUD3 | FDA UDI | Class II | Active |
| Ena HRI ® | EHR6B | EUDAMEDFDA UDI | Class II | Active |
| Amcop Bioactivator | BIO-F2M | FDA UDI | Class I | Active |
| Amcop Bioactivator | BS4-DEEP | FDA UDI | Class I | Active |
| Amcop Bioactivator | B0S5-DEEPH | FDA UDI | Class I | Active |
| Amcop Bioactivator | BTC2-DCMH | FDA UDI | Class I | Active |
| Amcop Bioactivator | BIO-BS5HM | FDA UDI | Class I | Active |
| Ena HRI ® | EHF6N | EUDAMEDFDA UDI | Class II | Active |
| Amcop Bioactivator | B0S4-DEEP | FDA UDI | Class I | Active |
| Amcop Bioactivator | BIO-SC5M | FDA UDI | Class I | Active |
| Ena HRI ® | EHF3N | EUDAMEDFDA UDI | Class II | Active |
| Amcop Bioactivator | B0S2-DEEP | FDA UDI | Class I | Active |
| Amcop Bioactivator | BTC5-DTM | FDA UDI | Class I | Active |
| Amcop Bioactivator | BS2-DCM | FDA UDI | Class I | Active |
| Ena Bond ® | CFOTP-2 | FDA UDI | Class II | Active |
| Ena Seal ® | COSZ10 | EUDAMEDFDA UDI | Class II | Active |
| Ena HRI ® | EFFUD6 | EUDAMEDFDA UDI | Class II | Active |
| Amcop Bioactivator | BS5-DCM | FDA UDI | Class I | Active |
| Amcop Bioactivator | B0S1-DCMH | FDA UDI | Class I | Active |
| Amcop Bioactivator | BC1-DCMH | FDA UDI | Class I | Active |
| Ena Shiny | ES+G | FDA UDI | Class I | Active |
| Ena Shiny | ESA | FDA UDI | Class I | Active |
| Ena HRI ® | EHRFUD6 | FDA UDI | Class II | Active |
| Amcop Bioactivator | BF5-DEEPH | FDA UDI | Class I | Active |
| Ena Tender ® | ETOD | FDA UDI | Class II | Active |
| Amcop Bioactivator | BC4-DCMH | FDA UDI | Class I | Active |
| Ena HRI ® | EHRIW | FDA UDI | Class II | Active |
| Ena HRI ® | EHRTBD6 | FDA UDI | Class II | Active |
| Amcop Bioactivator | BIO-DA1M | FDA UDI | Class I | Active |
| Ena HFO ® | EHFB3 | FDA UDI | Class II | Active |
| Amcop Bioactivator | B0S1-DTM | FDA UDI | Class I | Active |
| Amcop Bioactivator | B0S5-DCM | FDA UDI | Class I | Active |
| Amcop Bioactivator | BIO-0S4M | FDA UDI | Class I | Active |
| Elastoosas | BIO-OSAS3M | FDA UDI | Class I | Active |
| Amcop Bioactivator | BC5-DEEPH | FDA UDI | Class I | Active |
| Ena Shiny | ESS | FDA UDI | Class I | Active |
| Amcop Bioactivator | BIO-TC4M | FDA UDI | Class I | Active |
| Ena Bond ® | CFOTS-2 | FDA UDI | Class II | Active |
| Amcop Bioactivator | BSC5-DTM | FDA UDI | Class I | Active |
| Ena HRI ® | EHFS | EUDAMEDFDA UDI | Class II | Active |
| Amcop Bioactivator | BF5-DEEP | FDA UDI | Class I | Active |
| Amcop Bioactivator | BIO-F3HM | FDA UDI | Class I | Active |
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