Manufacturer registered with FDA
Silfradent srl
S.Sofia, Italy. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 6
- 510(k) clearances
- 12009–2009
- Markets registered in
- 931 registrations outside the US
- Establishments
- 1Italy
510(k) clearances per year, 2000–2026
Registered in 9 markets
Where regulators' registries name Silfradent srl 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 | Silfradent srl | 1 clearances | 2009–2009 | Below |
| Taiwan | TFDA | Manufacturer | SILFRADENT S.R.L.SILFRADENT SRL | 12 | 2006–2020 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Silfradent S.R.L. | 6 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Silfradent SRL | 4 | 2015–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SILFRADENT S.r.lSilfradent S.r.l · Silfradent s.r.l. | 3 | 2006–2009 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SILFRADENT S.R.L. | 2 | 2016–2016 | Pure Global AI |
| Israel | AMAR | Manufacturer | Silfradent SRL | 2 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | SILFRADENT SRL | 1 | 2010–2010 | Pure Global AI |
| China | NMPA | Registration holder | 塞法登特股份有限公司SILFRADENT SRL | 1 | — | 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 Silfradent srl currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered Bone DrillDZI · Class 2 | Surgical drills & motors | Maker | Surgybone | 2009 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | SUNSHINE S3S EVO BRSUNSHINE S3S EVO SPSUNSHINE S3S EVO SS | 2012 |
| Anesthetic Tube WarmerEFC · Class 1 | — | Maker | APAG | 2022 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | IRRIGATION LINE | 2019 |
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 Silfradent srl as the applicant.
Some of these clearances are listed with FDA today by another company: Dentis Co., Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SILFRADENT SRLFDA reg. 3007607709 | S.Sofia Forli, Italy | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027473). 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.