EHD · Unit, X-Ray, Extraoral With Timer
Dental · 21 CFR 872.1800 · Class 2
Overview
| Product Code | EHD |
|---|---|
| Device Name | Unit, X-Ray, Extraoral With Timer |
| Regulation | 21 CFR 872.1800 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 189)
Showing 20 most recent of 189 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | Mar 20, 2026 | SESE |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | Mar 12, 2026 | SESE |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | Feb 19, 2026 | SESE |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | Feb 3, 2026 | SESE |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | Sep 4, 2025 | SESE |
| K242185 | Rextar Pro | Raypia Co., Ltd. | Dec 4, 2024 | SESE |
| K242591 | XERO-alpha | DRTECH Corporation | Nov 1, 2024 | SESE |
| K241963 | WERAY | Picopack Co., Ltd. | Jul 30, 2024 | SESE |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare | Jul 5, 2024 | SESE |
| K240759 | REMEX-GR100 | Remedi Co., Ltd. | May 13, 2024 | SESE |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | Feb 8, 2024 | SESE |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | Jan 3, 2024 | SESE |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | Dec 28, 2023 | SESE |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | Dec 8, 2023 | SESE |
| K232012 | N1 | Osstem Implant Co., Ltd. | Nov 28, 2023 | SESE |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | Sep 1, 2023 | SESE |
| K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | Jul 13, 2023 | SESE |
| K223780 | Lumos 3DX | 3Dio | Jul 6, 2023 | SESE |
| K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | Mar 3, 2023 | SESE |
| K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | Jan 17, 2023 | SESE |
Top Applicants
- Planmeca Oy — 13 clearances
- Villa Sistemi Medicali S.P.A. — 7 clearances
- VATECH Co., Ltd. — 6 clearances
- Trophy Radiologie — 6 clearances
- Instrumentarium Corp. — 4 clearances
