510(k) · Cleared
ClearedDental Extraoral Source X-Ray System (Esx)
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 9, 2009 as substantially equivalent to K000672 (Sirona Dental Systems GmbH, 2000) after an 87-day review. Its family tree reaches back 1 generation to 2000. 4 later devices descend from it.
- Decided
- Oct 9, 2009
- Review
- 87 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000672 (2000). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK000672 Heliodent VarioSirona Dental Systems GmbH · 2000
- This deviceK092103 Dental Extraoral Source X-Ray System (Esx)VATECH Co., Ltd. · 2009
- Descendant · cites it directly · 3 of its ownK123493 Vex-S 100W Intraoral X-Ray SystemVATECH Co., Ltd. · 2012
- Descendant · 2 generations on · 2 of its ownK163705 EzRay Air WVATECH Co., Ltd. · 2017
- Descendant · 3 generations on · 1 of its ownK223058 EzRay Air 2 Wall (Model: VEX-S350W)VATECH Co., Ltd. · 2022
- Descendant · 4 generations on · 0 of its ownK250839 Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K123493Vex-S 100W Intraoral X-Ray SystemVATECH Co., Ltd. · 2012 · cites it directly3descendants
- K163705EzRay Air WVATECH Co., Ltd. · 2017 · 2 generations on2descendants
- K223058EzRay Air 2 Wall (Model: VEX-S350W)VATECH Co., Ltd. · 2022 · 3 generations on1descendant
- K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000672 | Heliodent Vario | Sirona Dental Systems GmbH | 2000 | — |
| 0 (this device) | K092103 | Dental Extraoral Source X-Ray System (Esx) | VATECH Co., Ltd. | 2009 | — |
| +1 | K123493 | Vex-S 100W Intraoral X-Ray System | VATECH Co., Ltd. | 2012 | — |
| +2 | K163705 | EzRay Air W | VATECH Co., Ltd. | 2017 | — |
| +3 | K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | 2022 | — |
| +4 | 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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K000672 | Heliodent VarioSummary page 1…e Device: Manufacturer : Sirona Dental Systems GMBH Device : Heliodent Vario 510(k) Number : K000672 (Decision Date - May. 02. 2000) 4. Classifications Names & Citations: 21CFR 872.1800, EHD, Unit, X-ray, Extraoral With Ti… | 2000 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K123493 | Vex-S 100W Intraoral X-Ray System | 2012 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K123493 (VATECH Co., Ltd., 2012) has gone furthest, with 3 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. 2009, 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 ESX is an extraoral source of X-rays, intended to be used for producing diagnostic dental radiographs for treatment of disease of the teeth, jaw and oral structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092103 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092103: Dental Extraoral Source X-Ray System (Esx).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092103
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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