Data / Medical devices / Italy / Overfibers S.R.L
Overfibers S.R.L: FDA-registered device maker in IMOLA Bologna, Italy, 1 510(k) clearance
Overfibers S.R.L is registered with the FDA (registration 3030648980) in IMOLA Bologna, Italy. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030648980
- Address
- Via Malatesta, 7, IMOLA Bologna, Italy, 40026
- Owner or operator
- OVERFIBERS S.R.L (10092618)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- January 28, 2025
- Registered through
- 2026
- Brand names listed
- Conical Drill # Large, Conical Drill # Medium, Conical Drill # Small, Conical Over Post # Large, Conical Over Post # Medium, Conical Over Post # Small, Cylindrical Drill # 0,8, Cylindrical Drill # 1,0 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cement, Dental | EMA | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Post, Root Canal | ELR | 1 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| January 10, 2025 | K242366 | OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment | EMA | Substantially Equivalent | Overfibers S.R.L. | accessdata.fda.gov |
Compare with other makers
Updated January 10, 2025. 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.