Manufacturer registered with FDA
Azure Microdynamics, Inc.
Foothill Ranch, CA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Azure Microdynamics, 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 | Azure Microdynamics, Inc. | 1 device types | — | Below |
| South Korea | MFDS | Manufacturer | Azure MicroDynamics, Inc. | 1 | 2013–2013 | 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 Azure Microdynamics, 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 |
|---|---|---|---|---|
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | VECS Palate Expander | 2008 |
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
Azure Microdynamics, 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: Easy Access Orthodontics, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jan 1994 | K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. | EJF Orthodontic Metal Bracket |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| AZURE MICRODYNAMICS, INC.FDA reg. 3007279910 | Foothill Ranch, CA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10027145). 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.