510(k) · Cleared
ClearedOrthophos 5/Plus/CD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sirona Dental Systems GmbH · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Oct 22, 1998 after a 51-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 23 later devices descend from it.
- Decided
- Oct 22, 1998
- Review
- 51 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 0
23 later devices descend from it, 2 citing it directly.
- This deviceK983057 Orthophos 5/Plus/CDSirona Dental Systems GmbH · 1998
- Descendant · cites it directly · 16 of its ownK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- Descendant · 2 generations on · 15 of its ownK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- Descendant · 3 generations on · 7 of its ownK103711 Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011
- Descendant · 4 generations on · 5 of its ownK150217 Orthophos SLSirona Dental Systems GmbH · 2015
- Descendant · 3 generations on · 5 of its ownK122918 Rayscan a-ExpertRay Co., Ltd. · 2013
Showing 5 of 23 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 23 · See all- K013650Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001 · cites it directly16descendants
- K033073Orthophos XG DS/CephSirona Dental Systems GmbH · 2003 · 2 generations on15descendants
- K103711Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011 · 3 generations on7descendants
- K150217Orthophos SLSirona Dental Systems GmbH · 2015 · 4 generations on5descendants
- K122918Rayscan a-ExpertRay Co., Ltd. · 2013 · 3 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K983057 | Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 1998 | — |
| +1 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| +2 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| +3 | K103711 | Orthophos XG 3D / Ceph | Sirona Dental Systems GmbH | 2011 | — |
| +4 | K150217 | Orthophos SL | Sirona Dental Systems GmbH | 2015 | — |
| +3 | K122918 | Rayscan a-Expert | Ray Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 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 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (23)
See all 232 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?
- Of its descendants, K013650 (Sirona Dental Systems GmbH, 2001) has gone furthest, with 16 descendants of its own.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Orthopllos 5/PLUS/CD is an extraoral X-ray system intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The system allows for panoramic tomograpllic imaging, teleradiography, and transverse slice imaging.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K983057 · printed Nov 6, 2026
Cite this page
510(k) Report. “K983057: Orthophos 5/Plus/CD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K983057
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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