510(k) · Cleared
ClearedDentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentimax · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Oct 30, 2009 as substantially equivalent to K050693 (Air Techniques, Inc., 2005) after a 72-day review. Its family tree reaches back 1 generation to 2005. 2 later devices descend from it.
- Decided
- Oct 30, 2009
- Review
- 72 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K050693 (2005). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK050693 AccentAir Techniques, Inc. · 2005
- This deviceK092547 Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb…Dentimax · 2009
- Descendant · cites it directly · 0 of its ownK251206 Digital X-Ray DentiMax Pro Imaging SystemDentimax, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK220556 OpenSensorX SeriesDentimax, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K050693 | Accent | Air Techniques, Inc. | 2005 | — |
| 0 (this device) | K092547 | Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box | Dentimax | 2009 | — |
| +1 | K251206 | Digital X-Ray DentiMax Pro Imaging System | Dentimax, Inc. | 2025 | — |
| +1 | K220556 | OpenSensorX Series | Dentimax, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 |
|---|---|---|---|
| * | K050693 | Accent | 2005 |
What descends from it? (2)
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?
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. 2009, this device’s year, is highlighted.
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?
DentiMax Digital X-ray imaging System is intended to be used with standard digital X-ray systems to collect dental x-rays photos and convert them into electronic impulses that may be stored, viewed, and manipulated by dentists for the 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/K092547 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092547: Dentimax Digital X-Ray Imaging System Sensor Size 1, 2, Dentimax Usb Control Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092547
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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