Manufacturer registered with FDA
Epica International
Landrum, SC, United States. Lists 1 dental device type with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 12019–2019
- Markets registered in
- 33 registrations outside the US
- Establishments
- 2Italy, United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Epica International 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 | Epica International | 1 clearances | 2019–2019 | Below |
| European Union | EUDAMED | Manufacturer | Imaginalis Srl | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | IMAGINALIS S.r.l. | 1 | 2025–2025 | 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 Epica International 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 Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | SEE FACTOR CT3SeeFactor CT3 | 2020 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EPICA HUMAN HEALTHFDA reg. 3018596740 | Landrum, SC, United States | Complaint file establishment |
| Imaginalis S.r.l.FDA reg. 3012957335 | Sesto Fiorentino Firenze, Italy | Complaint file establishment, Manufacturer |
Other names on FDA records
IMAGINALIS S.r.l. · Epica Human Health
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10078585). 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.