510(k) · Cleared
ClearedDENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hdx Will Corp. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Oct 19, 2021 as substantially equivalent to K160140 (Hdx Will Corp., 2016) after a 92-day review. Its family tree reaches back 9 generations to 1997. 1 later device descends from it.
- Decided
- Oct 19, 2021
- Review
- 92 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K973598 (1997). 21 ancestors in all, the oldest K961826 (1996). 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations between
- 3 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 2 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 1 generation backK160140 DENTRIa seriesHdx Will Corp. · 2016
- This deviceK212254 DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp. · 2021
- Descendant · cites it directly · 0 of its ownK250839 Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd. · 2026
Show all 9 generations
- Root · 9 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
- 7 generations backK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
- 6 generations backK060328 Planmeca Promax 3DPlanmeca Oy · 2006
- 5 generations backK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
- 4 generations backK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 3 generations backK131695 Rayscan a-Expert 3DRay Co., Ltd. · 2013
- 2 generations backK142247 Rayscan a-Expert 3DRay Co., Ltd. · 2015
- 1 generation backK160140 DENTRIa seriesHdx Will Corp. · 2016
- This deviceK212254 DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa)Hdx Will Corp. · 2021
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 |
|---|---|---|---|---|---|
| −9 | K973598 | Siremobil CO2 | Siemens Medical Solutions USA, Inc. | 1997 | 1 |
| −8 | K030450 | 3D Accu-I-Tomo Xyz Slice View Tomograph | J. Morita USA, Inc. | 2003 | — |
| −7 | K052587 | 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf | J. Morita USA, Inc. | 2005 | — |
| −6 | K060328 | Planmeca Promax 3D | Planmeca Oy | 2006 | — |
| −5 | K111152 | Rotograph Evo 3D | Villa Sistemi Medicali S.P.A. | 2011 | 1 |
| −4 | K122981 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −3 | K131695 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2013 | — |
| −2 | K142247 | Rayscan a-Expert 3D | Ray Co., Ltd. | 2015 | — |
| −1 | K160140 | DENTRIa series | Hdx Will Corp. | 2016 | — |
| 0 (this device) | K212254 | DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) | Hdx Will Corp. | 2021 | — |
| +1 | 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 | 2 | 0 |
| 2001 | 2 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
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 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? (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 |
|---|---|---|---|
| * | K160140 | DENTRIa seriesSummary page 5…Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow; Predicate device - 510(k) Number: K160140 - Applicant: HDX WILL Corp. - Device Name: DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) - Regula… | 2016 |
| † | K192737 | RCT800 | 2019 |
| † | K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | 2018 |
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 24 years and passes through 6 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 21 ancestors have a recall of any class.
- Of its descendants, K250839 (Changzhou Boen Zhongding Medical Technology Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K160140.
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. 2021, 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 DENTRIα series is a Computed Tomography X-Ray imaging device specialized in diagnosing general dental treatments and orthodontic purpose using Panoramic and Cephalometric images respectively. In addition DENTRIα series is used in the field of Otolaryngology by capturing 360 degree rotation sequence of the head and neck areas, including the ENT and dentomaxillofacial areas for a dental treatment in adult and pediatric dentistry and obtains x-ray images from different angles and calculate through computer-processed to produce 3D x-ray tomographic images. The DENTRIα series used by physicians, dentists, and x-ray technologists.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212254 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212254: DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212254
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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