Registered with FDA
Apixia, Inc.
City of Industry, CA, United States. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 0
- 510(k) clearances
- 12012–2012
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Apixia, 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 | Lister | Apixia, Inc. | 1 clearances | 2012–2012 | Below |
| China | NMPA | Registration holder | 爱必加公司APIXIA 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 Apixia, 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 |
|---|---|---|---|---|
| X-Ray Film HolderEGZ · Class 1 | — | Lister | — | 2010 |
| X-Ray Beam AlignerEHA · Class 1 | — | Lister | — | 2010 |
| Extraoral with Timer X-Ray UnitEHD · Class 2 | Dental X-ray units | Lister | — | 2010 |
| Digital Extraoral Source X-Ray SystemMUH · Class 2 | Dental X-ray units | Lister | — | 2012 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | — | 2011 |
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
Apixia, Inc. 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: Dentamerica (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 24 Apr 2006 | K060640 | DIGIREX DIGITAL DENTAL RADIOGRAPHY SYSTEM | Dentamerica | EHD Extraoral with Timer X-Ray Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| APIXIA INC.FDA reg. 3008361230 | City of Industry, CA, United States | Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031841). 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.