Manufacturer registered with FDA
Koros USA Inc
Moorpark, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 5111 registrations outside the US
- Establishments
- 1United States
Registered in 5 markets
Where regulators' registries name Koros USA 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 | Koros USA Inc | 2 device types | — | Below |
| South Korea | MFDS | Manufacturer | Koros USA, IncKoros USA, Inc. · KOROS USA,INC. · +2 | 70 | 2000–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Koros USA Inc | 22 | 2012–2018 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | KOROS USA, INC.KOROS USA INC · Koros USA, Inc. | 14 | 2006–2026 | Pure Global AI |
| Israel | AMAR | Manufacturer | KOROS USA,Inc.KOROS USA, INC · Koros USA, Inc · +1 | 5 | — | 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 Koros USA 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 |
|---|---|---|---|---|
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | UNIT, SUCTION OPERATORY | 2000 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | SCISSORS, SURGICAL TISSUE, DENTAL | 1994 |
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 |
|---|---|---|
| KOROS USA, INC.FDA reg. 2023918 | MOORPARK, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 2023918). 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.