FDA product code · Dental
EHDUnit, X-Ray, Extraoral With Timer
Product code EHD covers Unit, X-Ray, Extraoral With Timer, a Class II device regulated under 21 CFR 872.1800. FDA has cleared 190 devices in this code, 6 of them in the last 12 months. Median review time across the 190 most recent decisions is 66 days. openFDA lists 18 recall records against this code.
Updated · ingest status · JSON
- Class
- Class II
- Regulation
- 21 CFR 872.1800
- Review panel
- Dental
- Clearances
- 190
What is happening in EHD right now?
EHD (Unit, X-Ray, Extraoral With Timer) has two findings, most consequential first. 4 first-time filers in the last 12 months, including PDX Co., Ltd. and Dental Imaging Technologies Corporation (K260367, K253864, K252110, K254018). The code is crowded, scoring 84 of 100 — 115 companies hold a clearance here and 6 arrived in the last 12 months (EHD:crowding).
| Finding | How much it matters | FDA records |
|---|---|---|
| New entrant | Worth knowing | K260367, K253864, K252110, K254018 |
| Crowding | Context | EHD:crowding |
Sources checked: predicate ancestry, recalls, adverse events, new entrants, review time, crowding. Composed . Every finding carries the record ids it was derived from; nothing here is an estimate.
How many devices has FDA cleared in EHD?
FDA has cleared 190 devices under product code EHD since the 510(k) programme began in 1976, 6 of them in the last 12 months.
Source: openFDA device/510k · retrieved
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | |
| K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | |
| K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | |
| K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., Ltd. | |
| K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | |
| K251438 | Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray ) | Guilin Woodpecker Medical Instrument Co., Ltd. | |
| K242185 | Rextar Pro | Raypia Co., Ltd. | |
| K242591 | XERO-alpha | DRTECH Corporation | |
| K241963 | WERAY | Picopack Co., Ltd. | |
| K241305 | LifeRay Intraoral Handheld X-ray System | Lucas Lifecare |
How long does FDA review take for EHD?
The median FDA review time for EHD is 66 days, measured across the 190 most recent decisions with both a received date and a decision date.
Review time here is decision date minus date received, as published by FDA. It is elapsed calendar time, not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Are there recalls in EHD?
openFDA lists 18 recall records against product code EHD. A recall record covers one firm's corrective action and may span many device lots.
Z-2117-2025Open, ClassifiedDIGIMED CO., LTD
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
Z-0517-2018TerminatedPanoramic Rental Corp.
The lift motor used to raise and lower the overhead chassis will wear if not properly maintained according to the maintenance schedule.
Z-0016-2017TerminatedPanoramic Rental Corp.
Panoramic Corporation is performing a voluntary Medical Device Correction on certain PC-1000 X-ray systems due to the potential for a safety nut to be ineffective, which could result in blunt force trauma that may impact the head, neck or shoulders.
Z-2716-2016TerminatedAribex Inc
Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.
Z-2717-2016TerminatedAribex Inc
Firm received customer complaints where end users reported that Nomad Pro and Pro 2 handsets had appeared to "overheat", "melt", "smoke" and/or "ignite." Investigation found that the internal lithium ion batteries had entered into a thermal runaway condition as a result of a short circuit on the battery pack PCB.
Showing the 5 most recently initiated of 18. Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Status is FDA's own wording; a terminated recall is a closed one, and the total spans the code's whole history, not just what is open today.
Source: openFDA device/recall · retrieved
How many adverse events are reported for EHD?
MAUDE holds 8 adverse-event reports naming product code EHD.
MAUDE reports are submitted by manufacturers, importers, user facilities and the public. They are unverified, and a report is not proof that the device caused the event.
Source: openFDA device/event · retrieved
Is adverse-event reporting in EHD unusual?
EHD does not yet have twelve months of adverse-event history in our data, so there is no expected range to compare against. That is a gap in what we hold, not a statement about the device.
| Month | Reports | Expected | Verdict |
|---|---|---|---|
| 2 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history | |
| 4 | Insufficient history | No expected range — too little history | |
| 1 | Insufficient history | No expected range — too little history |
4 months do not have a full, unbroken year of history before them, so no expected range is shown for those. Insufficient history is reported as insufficient rather than as zero: an empty baseline would turn a gap in our data into a spike.
Who has entered EHD in the last year?
4 companies filed in EHD for the first time in the last 12 months.
| Company | First cleared | K-number |
|---|---|---|
| PDX Co., Ltd. | K260367 | |
| Dental Imaging Technologies Corporation | K253864 | |
| Guangzhou Ajax Medical Equipment Co., Ltd. | K252110 | |
| Guilin Refine Medical Instrument Co., Ltd. | K254018 |
"First time" means their first clearance in this product code, not their first ever — an established manufacturer entering a new category is exactly the movement worth knowing about.
Source: openFDA device/510k · retrieved
What are the predicate devices in EHD?
FDA publishes no machine-readable predicate field, so no predicate chain is recorded for this code yet.
A predicate chain matters because a device inherits the safety history of what it was compared to. FDA publishes the chain only inside each 510(k) summary PDF, never as data — so where we have edges, they are read from those documents, and where we do not, we say so instead of showing an empty list.
Who files 510(k)s in EHD?
Across the 190 most recent decisions, these applicants filed most often in EHD.
| Applicant | Recent clearances |
|---|---|
| Planmeca Oy | 13 |
| Villa Sistemi Medicali S.P.A. | 7 |
| Trophy Radiologie | 6 |
| VATECH Co., Ltd. | 6 |
| Dentsply Intl. | 4 |
Applicant names above are exactly as FDA published them, so one company can appear under several spellings.
The same makers, after name resolution
One company in EHD files under more than one spelling. Resolving them to one identity — across all six datasets, not just this one — is what makes a joined count possible at all.
| Company | Clearances | FDA spellings merged |
|---|---|---|
| DIGIMED CO., LTD | 6 | 2 |
Merges are measured against a hand-labelled sample and held above 98% precision; pairs the matcher is unsure of are queued for a person rather than merged. See DeviceSignal.
Source: openFDA device/510k · retrieved
Watch EHD
Get an email the morning anything changes in EHD — a new clearance, a recall, or an adverse-event spike above this code's own baseline.
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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.