Manufacturer registered with FDA
Bioloren S.R.L.
SARONNO, Italy. Lists 6 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 32011–2018
- Markets registered in
- 525 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Bioloren S.R.L. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Bioloren S.R.L. | 3 clearances | 2011–2018 | Below |
| Canada | Health Canada | Registration holder | BIOLOREN S.R.L. | 16 | 2015–2020 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | Bioloren S.r.l. | 6 | 2017–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BIOLOREN S.R.L. | 2 | 2017–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | Bioloren SRL | 1 | 2022–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Bioloren S.R.L. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | FIBER DISK AND BLOCK PERMANENT,TRILOR | 2013 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Bioloren drill | 2018 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Fiber Disks and Blocks | 2011 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | INFIBRA | 2006 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | InFibra scissor | 2018 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | post | 2003 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Bioloren S.R.L. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 24 Feb 2018 | K173643 | Trilor Disks, Blocks and Arches | EBF Resin Tooth Shade Material |
| 21 Feb 2013 | K121735 | FIBER DISK AND BLOCK PERMANENT, TRINIA | EBF Resin Tooth Shade Material |
| 8 Nov 2011 | K112186 | FIBER DISK AND BLOCK | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Dental Laboratory Milling Supplies LLC, DBA Digital Dental, (1), Smart Denture Conversions, LLC (1).
Also lists devices cleared under other names
Bioloren S.R.L. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Global Dental Products, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 Sep 2006 | K061735 | INFIBRA, MODEL 1200 | Global Dental Products, Inc. | EBI Rebasing Repairing Relining Denture Resin |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOLOREN SRLFDA reg. 3003231822 | SARONNO Varese, Italy | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9059794). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.