510(k) · Cleared
ClearedDentron Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentron Systems, LLC · EAP Unit, X-Ray, Intraoral
Cleared on May 13, 2008 as substantially equivalent to K061114 (Cefla S.C.R.L., 2006) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 1999. 3 later devices descend from it.
- Decided
- May 13, 2008
- Review
- 57 days
- Class
- Class II
- Product code
- EAP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K990002 (1999). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK990002 Quickray DSX 730Julie Alliance · 1999
- 1 generation backK061114 WDS, Size 2 and Size 2Cefla S.C.R.L. · 2006
- This deviceK080738 Dentron SensorDentron Systems, LLC · 2008
- Descendant · cites it directly · 2 of its ownK092537 Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540Toshiba America Electronic Components, Inc. · 2009
- Descendant · 2 generations on · 1 of its ownK110886 Clio/CliosoftSota Precision Optics, Inc. · 2011
- Descendant · 3 generations on · 0 of its ownK241495 Jazz ClassicJazz Imaging · 2024
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 | K990002 | Quickray DSX 730 | Julie Alliance | 1999 | — |
| −1 | K061114 | WDS, Size 2 and Size 2 | Cefla S.C.R.L. | 2006 | — |
| 0 (this device) | K080738 | Dentron Sensor | Dentron Systems, LLC | 2008 | — |
| +1 | K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 | Toshiba America Electronic Components, Inc. | 2009 | — |
| +2 | K110886 | Clio/Cliosoft | Sota Precision Optics, Inc. | 2011 | — |
| +3 | K241495 | Jazz Classic | Jazz Imaging | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2024 | 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 EAP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K061114 | WDS, Size 2 and Size 2Summary page 1…Louisiana and is new to the market. The intended device is similar in intended use, material, safety and effectiveness in similar applications to: CEFLA s.l.r.’s MyRay K061114, Air Technique’'s Accent K050693, and Julie Alliance’s QuickRay DSX 730 K990002. The device is to be distributed by Dentron Syst… | 2006 |
| * | K050693 | AccentSummary page 1…et. The intended device is similar in intended use, material, safety and effectiveness in similar applications to: CEFLA s.l.r.’s MyRay K061114, Air Technique’'s Accent K050693, and Julie Alliance’s QuickRay DSX 730 K990002. The device is to be distributed by Dentron Systems, LLC in the United States. T… | 2005 |
| * | K990002 | Quickray DSX 730Summary page 1…use, material, safety and effectiveness in similar applications to: CEFLA s.l.r.’s MyRay K061114, Air Technique’'s Accent K050693, and Julie Alliance’s QuickRay DSX 730 K990002. The device is to be distributed by Dentron Systems, LLC in the United States. The following voluntary standards are utilized i… | 1999 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K092537 | Digital X-Ray Sensor, Model E9539,E9505,E9502, E9540 | 2009 | 2 |
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 9 years and passes through 3 companies; a new generation was cleared every 7.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K092537 (Toshiba America Electronic Components, Inc., 2009) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K061114.
How does its category compare?
All EAP devicesEAP Unit, X-Ray, Intraoral: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · EAP
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · EAP
Too few EAP 510(k)s in any year since 2007 to give a median.
Recalls per year · EAP
3in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EAP
1in 2025
MAUDE reports naming product code EAP, 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 | 0 | — | 0 | 6 |
| 2008 | 1 | — | 0 | 18 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 3 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CCD area image sensor is intended to capture an intraoral x-ray image, when exposed to x-rays, for dental diagnostic purposes.
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/K080738 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080738: Dentron Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080738
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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