EHD — Unit, X-Ray, Extraoral With Timer Class II
FDA product code EHD covers "Unit, X-Ray, Extraoral With Timer", a Class II medical device regulated under 21 CFR 872.1800. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EHD
- Device Class
- Class II
- Regulation Number
- 872.1800
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260367 | pdx co | Portable Dental X-ray System Model PDX nova | May 27, 2026 |
| K253864 | dental imaging technologies corporation | NOMAD Pro 3 | March 20, 2026 |
| K252110 | guangzhou ajax medical equipment co | Dental X-RAY Unit (AJX200) | March 12, 2026 |
| K254018 | guilin refine medical instrument co | Portable Dental X-ray Device (GT-1) | February 19, 2026 |
| K252909 | ningbo runyes medical instrument co | Diagnostic X-Ray Equipment Model POCT22 | February 3, 2026 |
| K251438 | guilin woodpecker medical instrument co | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | September 4, 2025 |
| K242185 | raypia co | Rextar Pro | December 4, 2024 |
| K242591 | drtech corporation | XERO-alpha | November 1, 2024 |
| K241963 | picopack co | WERAY | July 30, 2024 |
| K241305 | lucas lifecare | LifeRay Intraoral Handheld X-ray System | July 5, 2024 |
| K240759 | remedi co | REMEX-GR100 | May 13, 2024 |
| K233914 | shenzhen xpectvision technology co | XVbeam2000 | February 8, 2024 |
| K233395 | alliage s/a industrias médico odontológica | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | January 3, 2024 |
| K231055 | de götzen | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiolog | December 28, 2023 |
| K232085 | genoray co | DVAS (DVAS-M, DVAS-W) | December 8, 2023 |
| K232012 | osstem implant co | N1 | November 28, 2023 |
| K232068 | changzhou sifary medical technology co | HyperLight Portable X-ray Unit | September 1, 2023 |
| K231449 | ningbo runyes medical instrument co | Portable X-ray System Model Ray98(P) | July 13, 2023 |
| K223780 | 3dio | Lumos 3DX | July 6, 2023 |
| K221587 | digimed co | DHX-70H, XTG-70H | March 3, 2023 |