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Sign in to claim this brandBIOLOREN SRL
US
Last updated May 23, 2026
What BIOLOREN SRL makes
Bioloren Srl manufactures preformed dental implant suprastructures designed for permanent use, as well as temporary resin-based crowns and bridges for restorative procedures. Their portfolio includes root canal posts, dental drill bits for pin/post applications, and reinforcing fibres for dental restorations, all intended for use in endodontic and restorative treatments.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. Bioloren Srl operates from the United States, adhering to regulatory requirements for dental materials and instruments.
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 Bioloren Srl manufacture?
Bioloren Srl specializes in dental devices primarily used in restorative and endodontic treatments. Their portfolio includes preformed dental implant suprastructures for permanent use, temporary resin-based crowns and bridges, root canal posts, pin/post dental drill bits, and dental reinforcing fibres. These products are designed to support dental restoration procedures, such as fixing implants, repairing teeth, and reinforcing dental structures.
Where is Bioloren Srl based, and what regulatory requirements does it follow?
Bioloren Srl is based in the United States. Since their devices fall under FDA jurisdiction, they must comply with U.S. regulatory standards for dental materials and instruments. This includes adhering to classification rules, UDI requirements, and other applicable FDA guidelines to ensure safety, performance, and proper labeling for their dental products.
Which regulatory registries or databases list Bioloren Srl’s devices?
Bioloren Srl’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices throughout their distribution and use, ensuring transparency and traceability for regulatory and clinical purposes. This listing is essential for compliance with FDA requirements for certain device classifications.
How are Bioloren Srl’s devices classified under FDA regulations?
Bioloren Srl’s devices are classified under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area it interacts with, as outlined in FDA’s regulatory framework.
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
- 428561679
Catalogue (141)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Trilor | FBK602520P | FDA UDI | Class II | Active |
| Trilor | FDA25P | FDA UDI | Class II | Active |
| Trilor | FDZ20P | FDA UDI | Class II | Active |
| Trilor | FDA20T | FDA UDI | Class II | Active |
| Trilor | FBS854022T | FDA UDI | Class II | Active |
| Trilor | FDS16PP | FDA UDI | Class II | Active |
| Trilor | FDZ10P | FDA UDI | Class II | Active |
| Vivid Post White | B16-0032 | FDA UDI | Class I | Active |
| Infibra | IF2 | FDA UDI | Class II | Active |
| Vivid Post White | B16-0038 | FDA UDI | Class I | Active |
| Trilor | FDZ18PP | FDA UDI | Class II | Active |
| Trilor | FDA10P | FDA UDI | Class II | Active |
| Trilor | FDC18 | FDA UDI | Class II | Active |
| Trilor | FDC30 | FDA UDI | Class II | Active |
| Vivid Post Translucent | B16-0042 | FDA UDI | Class I | Active |
| Infibra | IF3 | FDA UDI | Class II | Active |
| Vivid Post Drill | B16-0066 | FDA UDI | Class I | Active |
| Trilor | FDZ16T | FDA UDI | Class II | Active |
| Trilor Arch | TA5.5NWPP | FDA UDI | Class II | Active |
| Trilor | FDZ10T | FDA UDI | Class II | Active |
| Trilor | FBS25T | FDA UDI | Class II | Active |
| Vivid Post Translucent | B16-0046 | FDA UDI | Class I | Active |
| Trilor | FDS18P | FDA UDI | Class II | Active |
| Trilor | FBK602520T | FDA UDI | Class II | Active |
| Trilor | FBK422020T | FDA UDI | Class II | Active |
| Infibra | IF1 | FDA UDI | Class II | Active |
| Trilor | FDZ12P | FDA UDI | Class II | Active |
| Trilor | FBS854022P | FDA UDI | Class II | Active |
| Infibra | IFKIT5 | FDA UDI | Class II | Active |
| Vivid Post Drill | B16-0072 | FDA UDI | Class I | Active |
| Trilor | FDA14T | FDA UDI | Class II | Active |
| Trilor | FDZ14PP | FDA UDI | Class II | Active |
| Trilor | FDZ25P | FDA UDI | Class II | Active |
| Trilor | FDZ18P | FDA UDI | Class II | Active |
| Vivid Post Drill | B16-0062 | FDA UDI | Class I | Active |
| Trilor | FDA25T | FDA UDI | Class II | Active |
| Trilor | FBS652522P | FDA UDI | Class II | Active |
| Trilor | FDS10P | FDA UDI | Class II | Active |
| Trilor | FDC20 | FDA UDI | Class II | Active |
| Trilor | FBS201514T | FDA UDI | Class II | Active |
| Trilor | FDS25P | FDA UDI | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Bioloren Srl SARONNO Varese · IT FEI 3003231822