Data / Medical devices / Aligner, Beam, X-Ray
Aligner, Beam, X-Ray (EHA): 8 FDA-registered makers in 4 countries
8 establishments in 4 countries are registered with the FDA to make Aligner, Beam, X-Ray (product code EHA, Class 1, 21 CFR 872.1820). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 1 510(k) clearance under this code, the latest on April 12, 1989, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- EHA
- Device class
- 1
- Regulation
- 872.1820
- Medical specialty
- Dental
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Taiwan | 1 |
| South Korea | 1 |
| China | 1 |
Makers of Aligner, Beam, X-Ray
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| A-dec, Inc. | Newberg, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply LLC | York, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dhef Inc. | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DXM Co., Ltd. | Jeonnam-Gwangju Special Metropolitan City, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Imaging Technologies Corporation | Quakertown, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dentsply Sirona Orthodontics Inc. | Sarasota, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinyuan Medical Equipment(tianjin)co.,ltd | Tianjin, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Poll Medical LLC | Beaverton, OR, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 12, 1989. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.