510(k) · Cleared
ClearedEDLENi Intra-Oral Sensor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Edlen Imaging, LLC · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Aug 26, 2015 as substantially equivalent to K103290 (Edlen Imaging, LLC, 2011) and 1 other predicate after a 152-day review. Its family tree reaches back 4 generations to 1994. 11 later devices descend from it.
- Decided
- Aug 26, 2015
- Review
- 152 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K933455 (1994). 7 ancestors in all. 11 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK933455 Computed Oral Radiology SystemSchick Technologies, Inc. · 1994
- 3 generations backK022953 Modification to Computed Oral Radiology SystemSchick Technologies, Inc. · 2002
- 2 generations backK072134 Schick Computed Oral Radiology SystemSchick Technologies, Inc. · 2007
- 1 generation backK103290 Edlen Imaging - Gemini DusbEdlen Imaging, LLC · 2011
- This deviceK150823 EDLENi Intra-Oral SensorEdlen Imaging, LLC · 2015
- Descendant · cites it directly · 10 of its ownK151926 QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015
- Descendant · 2 generations on · 2 of its ownK163282 Apex Dental SensorsMasterlink, LLC · 2017
- Descendant · cites it directly · 1 of its ownK162619 I View and Imagen SensorTrident S.R.L · 2016
- Descendant · 2 generations on · 0 of its ownK230916 WeSensorPicopack, Inc. · 2023
- Descendant · 3 generations on · 0 of its ownK202369 RXS 1000Rolence Enterprise, Inc. · 2021
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K151926QuickRay HD Intraoral SensorDenterprise International, Inc. · 2015 · cites it directly10descendants
- K163282Apex Dental SensorsMasterlink, LLC · 2017 · 2 generations on2descendants
- K162619I View and Imagen SensorTrident S.R.L · 2016 · cites it directly1descendant
- K230916WeSensorPicopack, Inc. · 2023 · 2 generations on0descendants
- K202369RXS 1000Rolence Enterprise, Inc. · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K933455 | Computed Oral Radiology System | Schick Technologies, Inc. | 1994 | — |
| −3 | K022953 | Modification to Computed Oral Radiology System | Schick Technologies, Inc. | 2002 | — |
| −2 | K072134 | Schick Computed Oral Radiology System | Schick Technologies, Inc. | 2007 | — |
| −1 | K103290 | Edlen Imaging - Gemini Dusb | Edlen Imaging, LLC | 2011 | — |
| 0 (this device) | K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | 2015 | — |
| +1 | K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | 2015 | — |
| +2 | K163282 | Apex Dental Sensors | Masterlink, LLC | 2017 | — |
| +1 | K162619 | I View and Imagen Sensor | Trident S.R.L | 2016 | — |
| +2 | K230916 | WeSensor | Picopack, Inc. | 2023 | — |
| +3 | K202369 | RXS 1000 | Rolence Enterprise, Inc. | 2021 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 0 |
| 2023 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K103290 | Edlen Imaging - Gemini DusbSummary page 4…o Classification Name: System, X-ray, Extraoral Source, Digital o 510K Number: K103290 o Product Code: MUH x Schick Technologies’ CDR system… | 2011 |
| * | K072134 | Schick Computed Oral Radiology SystemSummary page 4…o Classification Name: System, X-ray, Extraoral Source, Digital o 510K Number: K072134 o Product Code: MUH Product Description: The EDLENi sensor is an electronic medical device used… | 2007 |
What descends from it? (11)
See all 112 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?
- The line of descent spans 21 years and passes through 2 companies; a new generation was cleared every 5.1 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K151926 (Denterprise International, Inc., 2015) has gone furthest, with 10 descendants of its own.
- 1 other device also cites its predicate K103290.
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. 2015, 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 EDLENI sensor is an intra-oral x-ray sensor driven via CMOS technology indicated for the acquirement of intra-oral dental radiographs and intended for dental patients. The EDLENi will be handled via qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The sensors will be used to provide intra-oral radiographic images that ultimately diagnose general dental complications or abnormalities. The EDLENi sensor can be used in combination with positioning devices to facilitate alignment with the x-ray beam, or it may be positioned manually.
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/K150823 · printed Nov 5, 2026
Cite this page
510(k) Report. “K150823: EDLENi Intra-Oral Sensor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K150823
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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