510(k) · Cleared
Recalled · 2003Portable HDX Intraoral X-Ray
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentalez Group · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Jun 7, 2002 as substantially equivalent to K000061 (Minxray, Inc., 2000) after a 37-day review. Its family tree reaches back 1 generation to 2000. 48 later devices descend from it. It has been recalled once.
- Decided
- Jun 7, 2002
- Review
- 37 days
- Class
- Class II
- Product code
- EHD
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000061 (2000). 48 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000061 Minxray HF70D High Frequency Portable Dental X-Ray UnitMinxray, Inc. · 2000
- This deviceK021378 Portable HDX Intraoral X-RayDentalez Group · 2002
- Descendant · cites it directly · 47 of its ownK051795 Nomad Dental X-Ray SystemAribex, Inc. · 2005
- Descendant · 2 generations on · 24 of its ownK063121 Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007
- Descendant · 3 generations on · 18 of its ownK082167 Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · Recalled
- Descendant · 2 generations on · 17 of its ownK081664 Nomad Pro X-Ray SystemAribex, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 9 of its ownK173319 KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017
Showing 5 of 48 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 48 · See all- K051795Nomad Dental X-Ray SystemAribex, Inc. · 2005 · cites it directly47descendants
- K063121Portable X-Ray System, Model Port-X IIGenoray Co., Ltd. · 2007 · 2 generations on24descendants
- K082167Portable X-Ray System, Models Diox-602, ProxDigimed Corporation · 2008 · 3 generations on18descendants
- K081664Nomad Pro X-Ray SystemAribex, Inc. · 2008 · 2 generations on17descendants
- K173319KaVo NOMAD Pro 2 Handheld X-ray SystemAribex · 2017 · 3 generations on9descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | Minxray, Inc. | 2000 | — |
| 0 (this device) | K021378 | Portable HDX Intraoral X-Ray | Dentalez Group | 2002 | — |
| +1 | K051795 | Nomad Dental X-Ray System | Aribex, Inc. | 2005 | — |
| +2 | K063121 | Portable X-Ray System, Model Port-X II | Genoray Co., Ltd. | 2007 | — |
| +3 | K082167 | Portable X-Ray System, Models Diox-602, Prox | Digimed Corporation | 2008 | 1 |
| +2 | K081664 | Nomad Pro X-Ray System | Aribex, Inc. | 2008 | 2 |
| +3 | K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 6 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EHD? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EHD device
- #1 K260795 Hand-held Dental X-ray System (HyperLight-M)score 14.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000061 | Minxray HF70D High Frequency Portable Dental X-Ray Unit | 2000 |
What descends from it? (48)
See all 481 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051795 | Nomad Dental X-Ray System | 2005 | 47 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 16, 2003 | Not classified | Z-1272-02 | Other | problems with product label |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K051795 (Aribex, Inc., 2005) has gone furthest, with 47 descendants of its own.
How does its category compare?
All EHD devicesEHD Unit, X-Ray, Extraoral With Timer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · EHD
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EHD
58in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EHD
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EHD
6in 2024
MAUDE reports naming product code EHD, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 5 |
| 2008 | 5 | 49 | 0 | 6 |
| 2009 | 4 | 92 | 0 | 38 |
| 2010 | 4 | 268 | 3 | 47 |
| 2011 | 3 | 102 | 3 | 26 |
| 2012 | 2 | — | 0 | 22 |
| 2013 | 4 | 216 | 0 | 21 |
| 2014 | 3 | 107 | 1 | 20 |
| 2015 | 1 | — | 0 | 110 |
| 2016 | 2 | — | 1 | 63 |
| 2017 | 4 | 28 | 1 | 66 |
| 2018 | 5 | 30 | 0 | 21 |
| 2019 | 4 | 173 | 0 | 21 |
| 2020 | 2 | — | 0 | 4 |
| 2021 | 1 | — | 0 | 4 |
| 2022 | 8 | 58 | 0 | 4 |
| 2023 | 8 | 147 | 0 | 2 |
| 2024 | 7 | 58 | 0 | 6 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 6 | 128 | 0 | — |
What is it indicated for?
The Portable HDX Intraoral X-ray unit is intended for use only by a qualifiedtrained dentist or dental technician on both adult and pediatric subjects for taking diagnostic extraoral dental x-rays using intraoral image receptors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021378 · printed Nov 5, 2026
Cite this page
510(k) Report. “K021378: Portable HDX Intraoral X-Ray.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K021378
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026