510(k) · Cleared
ClearedOrthophos XG DS/Ceph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Oct 10, 2003 as substantially equivalent to K013650 (Sirona Dental Systems GmbH, 2001) after an 11-day review. Its family tree reaches back 2 generations to 1997. 15 later devices descend from it.
- Decided
- Oct 10, 2003
- Review
- 11 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972312 (1997). 3 ancestors in all. 15 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 1 generation backK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- This deviceK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- Descendant · cites it directly · 7 of its ownK103711 Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011
- Descendant · 2 generations on · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · cites it directly · 5 of its ownK122918 Rayscan a-ExpertRay Co., Ltd. · 2013
- Descendant · 2 generations on · 4 of its ownK131693 Rayscan a-ExpertRay Co., Ltd. · 2013
- Descendant · 2 generations on · 3 of its ownK142058 Rayscan a-ExpertRay Co., Ltd. · 2015
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K103711Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011 · cites it directly7descendants
- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · 2 generations on5descendants
- K122918Rayscan a-ExpertRay Co., Ltd. · 2013 · cites it directly5descendants
- K131693Rayscan a-ExpertRay Co., Ltd. · 2013 · 2 generations on4descendants
- K142058Rayscan a-ExpertRay Co., Ltd. · 2015 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −1 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| 0 (this device) | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| +1 | K103711 | Orthophos XG 3D / Ceph | Sirona Dental Systems GmbH | 2011 | — |
| +2 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +1 | K122918 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| +2 | K131693 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
| +2 | K142058 | Rayscan a-Expert | Ray Co., Ltd. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | 2001 |
What descends from it? (15)
See all 153 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 6 years and passes through 2 companies; a new generation was cleared every 4.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103711 (Sirona Dental Systems GmbH, 2011) has gone furthest, with 7 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.
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 Orthophos XGP"sDS/Ceph Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033073 · printed Nov 4, 2026
Cite this page
510(k) Report. “K033073: Orthophos XG DS/Ceph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K033073
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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