Manufacturer registered with FDA
Icrco, Inc.
Goleta, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 12012–2012
- Markets registered in
- 641 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Icrco, 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 | Icrco, Inc. | 1 clearances | 2012–2012 | Below |
| South Korea | MFDS | Manufacturer | iCRco, Inc.iCRco Inc. · iCRco,Inc. · +1 | 21 | 2007–2014 | Pure Global AI |
| Canada | Health Canada | Registration holder | ICRCO INC. | 15 | 2014–2016 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | ICRCO, INC. | 2 | 2018–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | ICRCO, INC. | 2 | 2011–2011 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | iCRco Inc. | 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 Icrco, 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 |
|---|---|---|---|---|
| Dental Computed Tomography X-RayOAS · Class 2 | Dental CBCT | Maker | Claris CBCTClaris XT | 2012 |
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 |
|---|---|---|
| iCRco Inc.FDA reg. 3009717300 | Goleta, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9022417). 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.