510(k) · Cleared
ClearedDexis Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dexis, LLC · MUH System, X-Ray, Extraoral Source, Digital
Cleared on May 28, 2009 as substantially equivalent to K072134 (Schick Technologies, Inc., 2007) and 1 other predicate after a 94-day review. Its family tree reaches back 3 generations to 1994. 18 later devices descend from it.
- Decided
- May 28, 2009
- Review
- 94 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K933455 (1994). 6 ancestors in all. 18 later devices descend from it, 7 citing it directly.
- Root · 3 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 2 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 1 generation backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- This deviceK090458 Dexis SensorDexis, LLC · 2009
- Descendant · cites it directly · 5 of its ownK210312 PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd. · 2021
- Descendant · cites it directly · 2 of its ownK202664 Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging · 2020
- Descendant · cites it directly · 2 of its ownK172918 DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC · 2017 · Recalled
- Descendant · 2 generations on · 1 of its ownK221955 Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging · 2022
- Descendant · 2 generations on · 1 of its ownK220422 Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd. · 2022
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K210312PlutoX Digital Intraoral X-Ray Imaging SystemIray Technology Taicang, Ltd. · 2021 · cites it directly5descendants
- K202664Clio Prime and Clio PedoSota Precision Optics, Inc. Dba Sota Imaging · 2020 · cites it directly2descendants
- K172918DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)Kavo Dental Technologies, LLC · 2017 · cites it directly2descendants
- K221955Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20Realcloud Imaging Inc. Dba Realcloud Imaging · 2022 · 2 generations on1descendant
- K220422Dental sensors NanoPix1, NanoPix2Iray Technology Taicang, Ltd. · 2022 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −2 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −1 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| 0 (this device) | K090458 | Dexis Sensor | Dexis, LLC | 2009 | — |
| +1 | K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang, Ltd. | 2021 | — |
| +1 | K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | 2020 | — |
| +1 | K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | Kavo Dental Technologies, LLC | 2017 | 1 |
| +2 | K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | 2022 | — |
| +2 | K220422 | Dental sensors NanoPix1, NanoPix2 | Iray Technology Taicang, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 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 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? (2)
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.
What descends from it? (18)
See all 187 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | 2021 | 5 |
| K202664 | Clio Prime and Clio Pedo | 2020 | 2 |
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | 2017 | 2 |
| K163224 | JAZZ SOLO Sensor | 2017 | 1 |
| K102456 | Intraoral Belsensor Gold | 2011 | 1 |
| K133206 | Z-Ray Intra-Oral Digital Radiography System | 2014 | 0 |
| K112380 | Clearvision | 2011 | 0 |
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 15 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K210312 (Iray Technology Taicang, Ltd., 2021) has gone furthest, with 5 descendants of its own.
- 11 other devices also cite its predicate K072134.
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?
The DEXIS sensor is a USB-driven digital sensor which is intended to acquire dental intra-oral radiography images. The DEXIS sensor shall be operated by healthcare professionals, who are educated and competent to perform the acquisition of dental intra-oral radiographs. The DEXIS sensor can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of the patient.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090458 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090458: Dexis Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090458
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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