510(k) · Cleared
ClearedModification to Sidexis Digital Radiography Imaging System
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 Dec 6, 2001 as substantially equivalent to K992644 (Sirona Dental Systems GmbH, 1999) after a 30-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- Dec 6, 2001
- Review
- 30 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K972168 (1997). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK972168 Sidexis Digital Radiography SystemPelton & Crane Co. · 1997
- 1 generation backK992644 Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 1999
- This deviceK013659 Modification to Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 2001
- Descendant · cites it directly · 1 of its ownK132773 Sidexis 4Sirona Dental Systems GmbH · 2013
- Descendant · 2 generations on · 0 of its ownK250755 DS Core DiagnosisDentsply Sirona, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK081903 Xios Plus Wall-ModuleSirona Dental Systems GmbH · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K972168 | Sidexis Digital Radiography System | Pelton & Crane Co. | 1997 | — |
| −1 | K992644 | Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | 1999 | — |
| 0 (this device) | K013659 | Modification to Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | 2001 | — |
| +1 | K132773 | Sidexis 4 | Sirona Dental Systems GmbH | 2013 | — |
| +2 | K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | 2025 | — |
| +1 | K081903 | Xios Plus Wall-Module | Sirona Dental Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2025 | 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 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? (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 |
|---|---|---|---|
| * | K992644 | Sidexis Digital Radiography Imaging SystemSummary page 2…BSTANTIAL EQUIVALENCE The SIDEXIS system that is the subject of this 510(k) premarket notification isa modification of STDEXIS as previously cleared for marketing under K992644. The modified SIDEXIS has the same intended use and principles of operation as the original SIDEXIS, as well as substantially equ… | 1999 |
What descends from it? (3)
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 4 years and passes through 2 companies; a new generation was cleared every 2.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132773 (Sirona Dental Systems GmbH, 2013) has gone furthest, with 1 descendant 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?
SIDEXIS is a digital radiography imaging system intended to replace conventional radiographic film for dental radiographic examination and diagnosis of diseases of the teeth,
jaw, and oral structures.
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/K013659 · printed Nov 5, 2026
Cite this page
510(k) Report. “K013659: Modification to Sidexis Digital Radiography Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K013659
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026