510(k) · Cleared
ClearedOrthophos XG 3D / Ceph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · OAS X-Ray, Tomography, Computed, Dental
Cleared on Mar 22, 2011 as substantially equivalent to K060892 (Sirona Dental Systems GmbH, 2006) and 1 other predicate after a 92-day review. Its family tree reaches back 3 generations to 1997. 7 later devices descend from it.
- Decided
- Mar 22, 2011
- Review
- 92 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K972312 (1997). 7 ancestors in all. 7 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 2 generations backK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- 1 generation backK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- This deviceK103711 Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011
- Descendant · cites it directly · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · 2 generations on · 1 of its ownK201140 AxeosDentsply Sirona · 2020
- Descendant · 3 generations on · 0 of its ownK253959 Primevision 3DDentsply Sirona · 2026
- Descendant · 2 generations on · 0 of its ownK213579 Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L · 2022
- Descendant · 2 generations on · 0 of its ownK191616 Orthophos SDentsply Sirona · 2019
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · cites it directly5descendants
- K201140AxeosDentsply Sirona · 2020 · 2 generations on1descendant
- K253959Primevision 3DDentsply Sirona · 2026 · 3 generations on0descendants
- K213579Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D CephFona S.R.L · 2022 · 2 generations on0descendants
- K191616Orthophos SDentsply Sirona · 2019 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −2 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| −1 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| 0 (this device) | K103711 | Orthophos XG 3D / Ceph | Sirona Dental Systems GmbH | 2011 | — |
| +1 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +2 | K201140 | Axeos | Dentsply Sirona | 2020 | — |
| +3 | K253959 | Primevision 3D | Dentsply Sirona | 2026 | — |
| +2 | K213579 | Stellaris 2D, Stellaris 2D Ceph, Stellaris 3D and Stellaris 3D Ceph | Fona S.R.L | 2022 | — |
| +2 | K191616 | Orthophos S | Dentsply Sirona | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 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 |
|---|---|---|---|
| * | K060892 | GalileosSummary page 1…sual Name: x-ray, tomography, computed, dental Classification Name: Computed tomography x-ray system 3 PREDICATE DEVICES Sirona GALILEOS (K060892) and Sirona ORTHOPHOS XGP'uS IDS (K033073) 4 INTENDED USE The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional i… | 2006 |
| * | K033073 | Orthophos XG DS/CephSummary page 1…y, computed, dental Classification Name: Computed tomography x-ray system 3 PREDICATE DEVICES Sirona GALILEOS (K060892) and Sirona ORTHOPHOS XGP'uS IDS (K033073) 4 INTENDED USE The ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconst… | 2003 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 14 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K150217 (Sirona Dental Systems GmbH, 2015) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K060892.
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. 2011, 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 ORTHOPHOS XG 3D/ Ceph is intended to produce two dimensional images and three dimensional volume reconstructions, including partial volumes and selected projections of the dentomaxillofacial areas, for use in planning and diagnostic support. Image acquisition, modes include panoramic X-ray, cephalometric X-ray, specialized tomographic X-ray, and cone beam tomography X-ray. The system can also acquire carpal exposures. The system includes an X-ray source, flat panel X-ray detector, positioning devices, as well as interactive 3D reconstruction, processing, and archiving software.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103711 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103711: Orthophos XG 3D / Ceph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103711
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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