Manufacturer registered with FDA
Sofic
Mazamet Cedex, France. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 59 registrations outside the US
- Establishments
- 1France
Registered in 5 markets
Where regulators' registries name Sofic 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 | Sofic | 2 device types | — | Below |
| Taiwan | TFDA | Manufacturer | SOFIC S.A.SOFIC | 5 | 1990–2013 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SOFICSOFIC S.A. | 2 | 1998–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Sofic | 1 | 2013–2013 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | SOFIC | 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 Sofic currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Effitec | 2002 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | — | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sofic lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Arent Fox (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SOFIC SASFDA reg. 3002987375 | Mazamet, Cedex Tarn, France | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9049286). 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.