EHD

Unit, X-Ray, Extraoral With Timer

Product code
EHD
Device name
Unit, X-Ray, Extraoral With Timer
Device class
Class 2
21 CFR
21 CFR 872.1800
Medical specialty
Dental
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
16
Summaries archived here
11 (direct download)
510(k) clearances (all years, FDA)
190 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (16)

Last three years. Most recent: 2026-05-27.

NumberDecision dateApplicantDevice nameSummary
K2603672026-05-27PDX Co., Ltd.Portable Dental X-ray System Model PDX novaFDA
K2538642026-03-20Dental Imaging Technologies Corporatio…NOMAD Pro 3PDF
K2521102026-03-12Guangzhou Ajax Medical Equipment Co., …Dental X-RAY Unit (AJX200)PDF
K2540182026-02-19Guilin Refine Medical Instrument Co., …Portable Dental X-ray Device (GT-1)PDF
K2529092026-02-03Ningbo Runyes Medical Instrument Co., …Diagnostic X-Ray Equipment Model POCT22PDF
K2514382025-09-04Guilin Woodpecker Medical Instrument C…Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master…PDF
K2421852024-12-04Raypia Co., Ltd.Rextar ProPDF
K2425912024-11-01DRTECH CorporationXERO-alphaPDF
K2419632024-07-30Picopack Co., Ltd.WERAYFDA
K2413052024-07-05Lucas LifecareLifeRay Intraoral Handheld X-ray SystemFDA
K2407592024-05-13Remedi Co., Ltd.REMEX-GR100
K2339142024-02-08Shenzhen Xpectvision Technology Co., L…XVbeam2000PDF
K2333952024-01-03Alliage S/A Industrias Médico Odontoló…Portable Dental X-Ray (AXR60 S); Portable Dental X-…FDA
K2310552023-12-28De Götzen S.R.L.x-mind dc (under trademark Acteon), Owandy-RX DC (un…PDF
K2320852023-12-08Genoray Co., Ltd.DVAS (DVAS-M, DVAS-W)PDF
K2320122023-11-28Osstem Implant Co., Ltd.N1PDF

11 summaries are archived here for direct download.

Official FDA classification page: EHD
Classification and pathway per current FDA publications. Data from openFDA (CC0).