FDA product code EHD: Unit, X-Ray, Extraoral With Timer
EHD is the FDA product code for unit, x-ray, extraoral with timer. It is a Class II device, regulated under 21 CFR 872.1800 and reviewed by the Radiology panel. FDA has cleared 191 510(k) submissions under EHD, 30 in the last five years, from 120 different applicants. The average 510(k) review took 97 days (median 67); 110 days on average over the last three years. FDA has posted 18 recalls for EHD devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Unit, X-Ray, Extraoral With Timer |
| Device class | Class II |
| Regulation | 21 CFR 872.1800 |
| Review panel | RA — Radiology |
| Medical specialty | Dental |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for EHD
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 4 | 38 |
| 2018 | 5 | 86 |
| 2019 | 4 | 205 |
| 2020 | 2 | 100 |
| 2021 | 1 | 114 |
| 2022 | 8 | 86 |
| 2023 | 8 | 156 |
| 2024 | 7 | 69 |
| 2025 | 1 | 118 |
| 2026 | 6 | 144 |
Compare with all 510(k) review times · Search every EHD clearance
Top EHD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Planmeca Oy | 13 | 2009-07-29 |
| Villa Sistemi Medicali S.P.A. | 7 | 2013-08-01 |
| VATECH Co., Ltd. | 6 | 2022-10-26 |
| Trophy Radiologie | 6 | 2004-02-20 |
| Digimed Co., Ltd. | 4 | 2023-03-03 |
115 more applicants have EHD clearances. See the full list in Caduvo.
Most recent EHD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260795 | Changzhou Sifary Medical Technology Co., Ltd. | Hand-held Dental X-ray System (HyperLight-M) | 2026-09-14 | 187 |
| K260367 | PDX Co., Ltd. | Portable Dental X-ray System Model PDX nova | 2026-05-27 | 112 |
| K253864 | Dental Imaging Technologies Corporation | NOMAD Pro 3 | 2026-03-20 | 107 |
| K252110 | Guangzhou Ajax Medical Equipment Co., Ltd. | Dental X-RAY Unit (AJX200) | 2026-03-12 | 248 |
| K254018 | Guilin Refine Medical Instrument Co., Ltd. | Portable Dental X-ray Device (GT-1) | 2026-02-19 | 66 |
Recalls for EHD devices
18 product recalls in 15 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2025-06-19.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2025 | 1 |
Frequently asked questions
What is FDA product code EHD?
EHD is the FDA product code for unit, x-ray, extraoral with timer. It is a Class II device, regulated under 21 CFR 872.1800 and reviewed by the Radiology panel.
What device class is EHD?
Class II, regulation 21 CFR 872.1800. Typical premarket route: 510(k).
How long does a 510(k) take for product code EHD?
Across 191 cleared submissions the average was 97 days from receipt to decision (median 67).
Which companies have the most EHD clearances?
Planmeca Oy (13); Villa Sistemi Medicali S.P.A. (7); VATECH Co., Ltd. (6); Trophy Radiologie (6); Digimed Co., Ltd. (4).
Have EHD devices been recalled?
Yes: 18 product recalls across 15 recall events; the most recent began 2025-06-19.
Next steps
- Run an FDA pathway report with predicate devices for product code EHD
- Run a recall and safety report across every EHD manufacturer
- Watch product code EHD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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