Overfibers S.R.L.
Active in EUDAMEDItalyfrom SRN EUDAMED FDA SRN IT-MF-000037545
- Devices
- 2
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA establishment
What Overfibers S.R.L. makes
Overfibers S.R.L. manufactures dental abutments and cementation systems for dental restorations, including titanium and ceramic abutments (OverCEM Ti-Abutment, OverCEM Cer-Abutment) and universal, translucent, and opaque dental cements (OverCEM SA).
These products are classified as Class II medical devices and are listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Hi-Rem Prosthetic Post Starter Kit Ref SKRPOP
CE MDD EUDAMEDOverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment Ref K242366
510(k) 510(k)
Company details
- EUDAMED SRN
- IT-MF-000037545
- EU VAT number
- IT01723440382
- EUDAMED status
- Active
- EUDAMED registered name
- Overfibers S.r.l.
- Registered address
- 7, Via Malatesta, 40026, Imola, Italy
- Website
- www.overfibers.com/
- [email protected]
- Phone
- +39 0542 730178
- PRRC contact
- Massimo Cardoni
FDA establishments
- Overfibers S.R.L IMOLA Bologna · IT FEI 3030648980
Frequently asked questions
How many devices does Overfibers S.R.L. have in the registry?
The registry currently lists 2 devices for Overfibers S.R.L.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Overfibers S.R.L.'s devices?
Among its 2 most recently registered devices, Overfibers S.R.L. has devices listed in EUDAMED (1 device) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Overfibers S.R.L.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Overfibers S.R.L.'s devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Overfibers S.R.L. in the registry?
The most recently registered devices listed for Overfibers S.R.L. include Hi-Rem Prosthetic Post Starter Kit and OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment.
Which FDA establishments are linked to Overfibers S.R.L.?
1 FDA establishment is linked to Overfibers S.R.L. in the registry; they are listed on the company page.