Manufacturer registered with FDA
Overfibers S.R.L.
IMOLA, Italy. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 77
- 510(k) clearances
- 12025–2025
- Markets registered in
- 622 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Overfibers 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 | Overfibers S.R.L. | 1 clearances | 2025–2025 | Below |
| Colombia | INVIMA | Registration holder | OVERFIBERS S.R.L | 11 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OVERFIBERS S.R.L. | 5 | 2009–2023 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | OVERFIBERS S.R.L | 3 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Overfibers S.r.l. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OVERFIBERS S.R.L. | 1 | 2018–2018 | 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 Overfibers 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 |
|---|---|---|---|---|
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | Conical Drill # LargeConical Drill # MediumConical Drill # SmallCylindrical Drill # 0,8Cylindrical Drill # 1,0Cylindrical Drill # 1,2Cylindrical Drill # 1,4Cylindrical Drill # 1,6Endontic Drill # 0Endontic Drill # 1 14 moreEndontic Drill # 2Endontic Drill # 3Endontic Drill # 4H-Endodontic Drill # 1H-Endodontic Drill # 2H-Endodontic Drill # 3Polygon Drill # 1Polygon Drill # 2Polygon Drill # 3Prosthetic Drill # 0Prosthetic Drill # 1Prosthetic Drill # 2Prosthetic Drill # 3Prosthetic Drill # 4 | 2025 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | Conical Over Post # LargeConical Over Post # MediumConical Over Post # SmallCylindrical Over Post # 0,8Cylindrical Over Post # 1,0Cylindrical Over Post # 1,2Cylindrical Over Post # 1,4Cylindrical Over Post # 1,6Cylindrical Over Post Black # 0,8Cylindrical Over Post Black # 1,0 37 moreCylindrical Over Post Black # 1,2Cylindrical Over Post Black # 1,4Cylindrical Over Post Black # 1,6Duo Over Post # 1Duo Over Post # 2Endodontic Over Post # 0Endodontic Over Post # 1Endodontic Over Post # 2Endodontic Over Post # 3Endodontic Over Post # 4Hi-Rem Endodontic Post # 1Hi-Rem Endodontic Post # 2Hi-Rem Endodontic Post # 3Hi-Rem Polygon Post # 1Hi-Rem Polygon Post # 2Hi-Rem Polygon Post # 3Hi-Rem Prosthetic Post # 0Hi-Rem Prosthetic Post # 1Hi-Rem Prosthetic Post # 2Hi-Rem Prosthetic Post # 3Hi-Rem+ # 0Hi-Rem+ # 1Hi-Rem+ # 2Hi-Rem+ # 3Over Post+ # 0Over Post+ # 1Over Post+ # 2Over Post+ # 3Over Post+ # 4Polygon Over Post # 1Polygon Over Post # 2Polygon Over Post # 3Prosthetic Over Post # 0Prosthetic Over Post # 1Prosthetic Over Post # 2Prosthetic Over Post # 3Prosthetic Over Post # 4 | 2025 |
| Dental CementEMA · Class 2 | Dental cements | Maker | NeobondOverCEM Cer-AbutmentOverCEM SA OpaqueOverCEM SA TranslucentOverCEM SA UniversalOverCEM Ti-Abutment | 2025 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OVERFIBERS S.R.LFDA reg. 3030648980 | IMOLA Bologna, Italy | Complaint file establishment, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10092618). 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.