Data / Medical devices / Italy / Silfradent SRL
Silfradent SRL: FDA-registered device maker in S.Sofia Forli, Italy, 1 510(k) clearance
Silfradent SRL is registered with the FDA (registration 3007607709) in S.Sofia Forli, Italy. It lists 5 device types. The FDA files 1 510(k) clearance under its listings, the newest dated April 1, 2009. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007607709
- Address
- via G.di Vittorio 35/37, S.Sofia Forli, Italy, 47018
- Owner or operator
- Silfradent srl (10027473)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 13, 2009
- Registered through
- 2026
- Brand names listed
- APAG, IRRIGATION LINE, MF200, Medifuge, SUNSHINE S3S EVO BR, SUNSHINE S3S EVO SP, SUNSHINE S3S EVO SS, Surgybone
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Chemistry, Centrifugal, For Clinical Use | JJG | 1 | Manufacturer | accessdata.fda.gov |
| Drill, Bone, Powered | DZI | 2 | Manufacturer | accessdata.fda.gov |
| Light, Operating, Dental | EAZ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Oral Irrigation | EFS | 1 | Exporter to the US | accessdata.fda.gov |
| Warmer, Anesthetic Tube | EFC | 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 |
|---|---|---|---|---|---|---|
| April 1, 2009 | K083569 | SURGYBONE | DZI | Substantially Equivalent | Silfradent S.R.L. | accessdata.fda.gov |
Compare with other makers
- All makers of Drill, Bone, Powered
- All makers of Analyzer, Chemistry, Centrifugal, For Clinical Use
- All makers of Unit, Oral Irrigation
- All makers of Light, Operating, Dental
- All makers of Warmer, Anesthetic Tube
Updated April 1, 2009. 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.