510(k) · Cleared
ClearedDental X-ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Changzhou Boen Zhongding Medical Technology Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Jun 11, 2026 as substantially equivalent to K212254 (Hdx Will Corp., 2021) and 1 other predicate after a 448-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Jun 11, 2026
- Review
- 448 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K973598 (1997). 27 ancestors in all, the oldest K961826 (1996). No later device cites it as a predicate yet.
- Root · 10 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations between
- 3 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 2 generations backK160140 DENTRIa seriesHdx Will Corp. · 2016
- 1 generation backK212254 DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp. · 2021
- This deviceK250839 Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026
Show all 10 generations
- Root · 10 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 9 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 8 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 7 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 6 generations backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- 5 generations backK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 4 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 3 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 2 generations backK160140 DENTRIa seriesHdx Will Corp. · 2016
- 1 generation backK212254 DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp. · 2021
- This deviceK250839 Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −9 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −8 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −7 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −6 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| −5 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −4 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −3 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| −2 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
| −1 | K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. | 2021 | — |
| 0 (this device) | K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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 OAS? 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 OAS device
- #1 K213226 RCT700score 18.0 · 13 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Summary page 5…Panel: Radiology Product Code: OAS 4. Identification of predicate Device [21 CFR 807.92(a)(3)] 510(K) number: K212254 Trade/Device Name: DENTRIα series Common name: x-ray, tomography, computed, dental Regulati… | 2021 |
| * | K223058 | EzRay Air 2 Wall (Model: VEX-S350W)Summary page 5…aphy x-ray system Regulation Class: Class 2 Panel: Radiology Product Code: OAS 510(K) number: K223058 510(k) Summary Page 1 of Page 15 Traditional 51… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 7 companies; a new generation was cleared every 2.6 years on median.
- 2 of the 27 ancestors have a recall of any class.
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 2025
MAUDE reports naming product code OAS, 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 | 2 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 1 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 6 | 168 | 0 | 0 |
| 2012 | 7 | 110 | 0 | 0 |
| 2013 | 10 | 155 | 0 | 0 |
| 2014 | 5 | 170 | 0 | 0 |
| 2015 | 5 | 164 | 1 | 0 |
| 2016 | 12 | 154 | 0 | 0 |
| 2017 | 4 | 209 | 0 | 0 |
| 2018 | 11 | 57 | 0 | 0 |
| 2019 | 7 | 55 | 0 | 1 |
| 2020 | 9 | 113 | 0 | 0 |
| 2021 | 11 | 92 | 0 | 0 |
| 2022 | 6 | 105 | 0 | 1 |
| 2023 | 12 | 77 | 0 | 1 |
| 2024 | 4 | 129 | 0 | 2 |
| 2025 | 9 | 144 | 3 | 1 |
| 2026 | 9 | 77 | 0 | — |
What is it indicated for?
The Dental X-ray System is a digital, extra-oral imaging system with panoramic, cephalometric, and tomographic capabilities, designed to: a. Produce orthopantomographic images of the maxillofacial region. b. Generate radiographs of the jaws, parts of the skull, and carpus for cephalometric examination, if equipped with a CEPH arm. c. Produce tomographic images of the head, including the ear, nose, and throat (ENT), the dentomaxillofacial complex, teeth…
Read the full statement (149 words)
The Dental X-ray System is a digital, extra-oral imaging system with panoramic, cephalometric, and tomographic
capabilities, designed to:
a. Produce orthopantomographic images of the maxillofacial region.
b. Generate radiographs of the jaws, parts of the skull, and carpus for cephalometric examination, if equipped with a
CEPH arm.
c. Produce tomographic images of the head, including the ear, nose, and throat (ENT), the dentomaxillofacial complex,
teeth, mandible, maxilla, temporomandibular joint (TMJ), and other areas of the human skull and neck, including sections
of the cervical spine, for diagnostic support.
If equipped with a Dental X-ray Unit, The Dental X-ray Unit is an extra-oral x-ray source for producing diagnostic dental
radiographic examination and diagnosis of teeth, jaw, and other oral structures using intra-oral image receptors (intra-oral
image receptors is not included in our Dental X-ray System).
The device is operated and used by physicians, dentists, radiologic technologists, and other qualified professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250839 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250839: Dental X-ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250839
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026