510(k) · Cleared
ClearedDental CT Scanner AXR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alliage S/A Industrias Medico Odontológica · OAS X-Ray, Tomography, Computed, Dental
Cleared on Apr 7, 2023 as substantially equivalent to K210820 (Alliage S/A Industrias Medico Odontológica, 2021) after a 108-day review. Its family tree reaches back 10 generations to 1997.
- Decided
- Apr 7, 2023
- Review
- 108 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 10 generations to K973598 (1997). 22 ancestors in all, the oldest K930338 (1993). 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 backK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- 2 generations backK152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
- 1 generation backK210820 EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021
- This deviceK223816 Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica · 2023
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 backK073350 Scanora 3DSoredex Palodex Group OY · 2007
- 5 generations backK093683 Orthopantomograph OP300Instrumentarium Dental, Palodex Group OY · 2010
- 4 generations backK111231 Panoura 18SThe Yoshida Dental Mfg. Co., Ltd. · 2011
- 3 generations backK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
- 2 generations backK152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
- 1 generation backK210820 EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021
- This deviceK223816 Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica · 2023
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 | K073350 | Scanora 3D | Soredex Palodex Group OY | 2007 | — |
| −5 | K093683 | Orthopantomograph OP300 | Instrumentarium Dental, Palodex Group OY | 2010 | — |
| −4 | K111231 | Panoura 18S | The Yoshida Dental Mfg. Co., Ltd. | 2011 | — |
| −3 | K122199 | PREXION3D Eclipse | The Yoshida Dental Mfg. Co., Ltd. | 2013 | — |
| −2 | K152489 | ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray | Panoramic Corp. | 2016 | — |
| −1 | K210820 | EAGLE EDGE AXR90 and AXR120 | Alliage S/A Industrias Medico Odontológica | 2021 | — |
| 0 (this device) | K223816 | Dental CT Scanner AXR | Alliage S/A Industrias Medico Odontológica | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K210820 | EAGLE EDGE AXR90 and AXR120Summary page 4…ulation Number 892.1750 Device Class 2 3. Legally Marketed Predicate Device Information: 510(k) Number: K210820 Manufacturer: Alliage S/A Industrias Medico Odontológica Trade /Proprietary Name EAGLE EDGE… | 2021 |
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 26 years and passes through 8 companies; a new generation was cleared every 2.6 years on median.
- 4 of the 22 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. 2023, 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 CT SCANNER AXR is designed to obtain 2D and 3D radiological images of the oral anatomy, including teeth, maxillofacial areas, oral structures, carpal images and head-neck bone regions. This system is exclusively for dental use and should be handled only by qualified health professionals.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223816 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223816: Dental CT Scanner AXR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223816
Report an extraction error
Are you the manufacturer?
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