510(k) · Cleared
ClearedSidexis 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 Aug 23, 1999 as substantially equivalent to K972168 (Pelton & Crane Co., 1997) after a 17-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- Aug 23, 1999
- Review
- 17 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K972168 (1997). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK972168 Sidexis Digital Radiography SystemPelton & Crane Co. · 1997
- This deviceK992644 Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 1999
- Descendant · cites it directly · 3 of its ownK013659 Modification to Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 2001
- Descendant · 2 generations on · 1 of its ownK132773 Sidexis 4Sirona Dental Systems GmbH · 2013
- Descendant · 3 generations on · 0 of its ownK250755 DS Core DiagnosisDentsply Sirona, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK081903 Xios Plus Wall-ModuleSirona Dental Systems GmbH · 2008
Most influential descendants
Showing 4 of 4 · See all- K013659Modification to Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 2001 · cites it directly3descendants
- K132773Sidexis 4Sirona Dental Systems GmbH · 2013 · 2 generations on1descendant
- K250755DS Core DiagnosisDentsply Sirona, Inc. · 2025 · 3 generations on0descendants
- K081903Xios Plus Wall-ModuleSirona Dental Systems GmbH · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K972168 | Sidexis Digital Radiography System | Pelton & Crane Co. | 1997 | — |
| 0 (this device) | K992644 | Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | 1999 | — |
| +1 | K013659 | Modification to Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | 2001 | — |
| +2 | K132773 | Sidexis 4 | Sirona Dental Systems GmbH | 2013 | — |
| +3 | K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | 2025 | — |
| +2 | K081903 | Xios Plus Wall-Module | Sirona Dental Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K972168 | Sidexis Digital Radiography SystemSummary page 1…Common/Usual Name: Digital X-ray Imaging System Classification Name: Accessory to Extraoral Source X-ray System 3. PREDICATE DEVICE SIDEXIS Digital Radiography System — K972168 4, INTENDED USE The SIDEXIS is a digital imaging system intended to replace conventional radiographic film for dental radiograph… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013659 | Modification to Sidexis Digital Radiography Imaging System | 2001 | 3 |
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?
- Its one ancestor has no recall.
- Of its descendants, K013659 (Sirona Dental Systems GmbH, 2001) has gone furthest, with 3 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 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/K992644 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992644: Sidexis Digital Radiography Imaging System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992644
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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