Manufacturer registered with FDA
PICOPACK Inc.
Daejeon, South Korea. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 22023–2024
- Markets registered in
- 22 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name PICOPACK Inc. 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 | PICOPACK Inc. | 2 clearances | 2023–2024 | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | PICOPACK IncPICOPACK Inc. | 2 | — | 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 PICOPACK Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Maker | WeRay | 2024 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Maker | MDPWeSensor | 2023 |
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 |
|---|---|---|
| PICOPACK Inc.FDA reg. 3029916103 | Daejeon, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10088890). 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.