Data / Medical devices / Italy / Bioloren SRL
Bioloren SRL: FDA-registered device maker in SARONNO Varese, Italy, 4 510(k) clearances
Bioloren SRL is registered with the FDA (registration 3003231822) in SARONNO Varese, Italy. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated February 24, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003231822
- Address
- Via Alessandro Volta 59, SARONNO Varese, Italy, IT-21047
- Owner or operator
- BIOLOREN SRL (9059794)
- Roles
- Manufacturer
- First device listed
- November 21, 2003
- Registered through
- 2026
- Brand names listed
- Bioloren drill, FIBER DISK AND BLOCK PERMANENT,, Fiber Disks and Blocks, INFIBRA, InFibra scissor, TRILOR, post
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Scissors, Surgical Tissue, Dental | EGN | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 24, 2018 | K173643 | Trilor Disks, Blocks and Arches | EBF | Substantially Equivalent | Bioloren S.R.L. | accessdata.fda.gov |
| February 21, 2013 | K121735 | FIBER DISK AND BLOCK PERMANENT, TRINIA | EBF | Substantially Equivalent | Bioloren S.R.L. | accessdata.fda.gov |
| November 8, 2011 | K112186 | FIBER DISK AND BLOCK | EBG | Substantially Equivalent | Bioloren S.R.L. | accessdata.fda.gov |
| September 8, 2006 | K061735 | INFIBRA, MODEL 1200 | EBI | Substantially Equivalent | Global Dental Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Post, Root Canal
- All makers of Scissors, Surgical Tissue, Dental
- All makers of Drill, Dental, Intraoral
- All makers of Material, Tooth Shade, Resin
- All makers of Crown And Bridge, Temporary, Resin
Updated February 24, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.