510(k) · Cleared
ClearedEzRay Air 2 Wall (Model: VEX-S350W)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
VATECH Co., Ltd. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Oct 26, 2022 as substantially equivalent to K163705 (VATECH Co., Ltd., 2017) after a 26-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it.
- Decided
- Oct 26, 2022
- Review
- 26 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K000672 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK000672 Heliodent VarioSirona Dental Systems GmbH · 2000
- 3 generations backK092103 Dental Extraoral Source X-Ray System (Esx)VATECH Co., Ltd. · 2009
- 2 generations backK123493 Vex-S 100W Intraoral X-Ray SystemVATECH Co., Ltd. · 2012
- 1 generation backK163705 EzRay Air WVATECH Co., Ltd. · 2017
- This deviceK223058 EzRay Air 2 Wall (Model: VEX-S350W)VATECH Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK250839 Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K000672 | Heliodent Vario | Sirona Dental Systems GmbH | 2000 | — |
| −3 | K092103 | Dental Extraoral Source X-Ray System (Esx) | VATECH Co., Ltd. | 2009 | — |
| −2 | K123493 | Vex-S 100W Intraoral X-Ray System | VATECH Co., Ltd. | 2012 | — |
| −1 | K163705 | EzRay Air W | VATECH Co., Ltd. | 2017 | — |
| 0 (this device) | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | 2022 | — |
| +1 | K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K163705 | EzRay Air WSummary page 4…Radiology 5. Predicate Device Information Manufacturer: VATECH Co., Ltd. Predicate device: EzRay Air Wall (Model: VEX-S300W) / K163705 Common or Usual Name: Dental X-ray system Regulation Classification: Extraoral source X-ray system (21 CFR… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K250839 | Dental X-ray System | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 2 companies; a new generation was cleared every 5.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K250839 (Changzhou Boen Zhongding Medical Technology Co., Ltd., 2026) has gone furthest, with 0 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. 2022, this device’s year, is highlighted.
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 EzRay Air 2 Wall (Model Name: VEX-S350W) is a dental X-ray system intended for use by a trained and qualified dentist or dental technician for both adult and pediatric subjects for producing diagnostic dental radiographs for the treatment of diseases of the teeth, jaw, and other oral structures using intra-oral image receptors.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223058 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223058: EzRay Air 2 Wall (Model: VEX-S350W).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223058
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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