Diagnostic devices · 21 CFR 872 Subpart B
X-Ray Beam Aligner
FDA device type “Aligner, Beam, X-Ray”.
- Companies listing it
- 167 makers
- Brands and models
- 14
- 510(k) clearances
- 10 in five years
- FDA name
- Aligner, Beam, X-Ray
510(k) clearances per year, 1976–2026
Companies that list EHA
16 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Uni-GRIPAR® · X-Ray Exposure Alignment (XCP® / XCP-ORA®) · XCP-DS® Sensor Holder | 148 | 2026 |
| Dental Imaging Technologies Corporation | United States | Maker | Alignment Bars | 2 | 2026 |
| A-dec, Inc. | United States | Maker | Bitewing Viewer | 68 | 2022 |
| Dxm Co., Ltd. | South Korea | Maker | DXPA · Multiple names | 6 | 2020 |
| Jinyuan medical equipment(tianjin)co.,ltd | China | Maker | N/A | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| POLL Medical | United States | Maker | Grayduck Stent | — | — |
| Sybron Dental Specialties | United States | Contract manufacturer | Dispose-a-Bite | 203 | 2026 |
| Pac-Dent Inc. | United States | Contract manufacturer | EzAim X-Ray Positioning System | 5 | 2022 |
| Dentamerica | United States | Repacker / relabeler | — | 4 | 2010 |
| Apixia, Inc. | United States | Repacker / relabeler | — | 1 | 2012 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | RAYXMED | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Manufacturer | X Ray | — | — |
| Ashtel Studios, Inc. | United States | Specification developer | — | — | — |
| Wolf X-Ray Corp | United States | Manufacturer | Bullseye Alignment Device | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 12 Apr 1989 | K891186 | REPOSITIONABLE BITEWING X-RAY FILM HOLDER KIT | Benn Research , Ltd. |
Official records: FDA product classification for EHA · 21 CFR 872.1820.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026