510(k) · Cleared
ClearedSidexis Digital Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pelton & Crane Co. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Sep 5, 1997 after an 88-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Sep 5, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK972168 Sidexis Digital Radiography SystemPelton & Crane Co. · 1997
- Descendant · cites it directly · 4 of its ownK992644 Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 1999
- Descendant · 2 generations on · 3 of its ownK013659 Modification to Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 2001
- Descendant · 3 generations on · 1 of its ownK132773 Sidexis 4Sirona Dental Systems GmbH · 2013
- Descendant · 4 generations on · 0 of its ownK250755 DS Core DiagnosisDentsply Sirona, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK081903 Xios Plus Wall-ModuleSirona Dental Systems GmbH · 2008
Most influential descendants
Showing 5 of 5 · See all- K992644Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 1999 · cites it directly4descendants
- K013659Modification to Sidexis Digital Radiography Imaging SystemSirona Dental Systems GmbH · 2001 · 2 generations on3descendants
- K132773Sidexis 4Sirona Dental Systems GmbH · 2013 · 3 generations on1descendant
- K250755DS Core DiagnosisDentsply Sirona, Inc. · 2025 · 4 generations on0descendants
- K081903Xios Plus Wall-ModuleSirona Dental Systems GmbH · 2008 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K972168 | Sidexis Digital Radiography System | Pelton & Crane Co. | 1997 | — |
| +1 | K992644 | Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | 1999 | — |
| +2 | K013659 | Modification to Sidexis Digital Radiography Imaging System | Sirona Dental Systems GmbH | 2001 | — |
| +3 | K132773 | Sidexis 4 | Sirona Dental Systems GmbH | 2013 | — |
| +4 | K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | 2025 | — |
| +3 | K081903 | Xios Plus Wall-Module | Sirona Dental Systems GmbH | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2001 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2025 | 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 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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992644 | Sidexis Digital Radiography Imaging System | 1999 | 4 |
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, K992644 (Sirona Dental Systems GmbH, 1999) has gone furthest, with 4 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 SIDEXIS Digital Radiography System consisting of digital sensor, image processing software, and CRT display is indicated to replace conventional radiographic film when used with extraoral source X-ray systems which are intended 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 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972168: Sidexis Digital Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972168
Report an extraction error
Are you the manufacturer?
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