510(k) · Cleared
ClearedDigirex Digital Dental Radiography System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentamerica · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Apr 24, 2006 as substantially equivalent to K031448 (Visiodent SA, 2003) and 2 other predicates after a 45-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Apr 24, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K925094 (1993). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK925094 Visualix Radiographic Image Detecting and ProcessGendex Corp. · 1993
- This deviceK060640 Digirex Digital Dental Radiography SystemDentamerica · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925094 | Visualix Radiographic Image Detecting and Process | Gendex Corp. | 1993 | — |
| 0 (this device) | K060640 | Digirex Digital Dental Radiography System | Dentamerica | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 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 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? (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 |
|---|---|---|---|
| * | K031448 | RSV (Radiology System VisiodentSummary page 1…or special controls exist for this device. Substantially Equivalent Legally Marketed Devices (predicates): RSV (Radiology System Visiodent) Device - K031448 EVA Digital Dental X-Ray System - K030647 Visualix Radiographic Image Detecting and Process - K925094 Intended… | 2003 |
| * | K030647 | Eva Digital Dental X-Ray SystemSummary page 1…. Substantially Equivalent Legally Marketed Devices (predicates): RSV (Radiology System Visiodent) Device - K031448 EVA Digital Dental X-Ray System - K030647 Visualix Radiographic Image Detecting and Process - K925094 Intended Use and Device Description: The Digirex… | 2003 |
| * | K925094 | Visualix Radiographic Image Detecting and ProcessSummary page 1…ates): RSV (Radiology System Visiodent) Device - K031448 EVA Digital Dental X-Ray System - K030647 Visualix Radiographic Image Detecting and Process - K925094 Intended Use and Device Description: The Digirex TM Digital Dental Radiography System replace… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 3 ancestors has a recall.
- 2 other devices also cite its predicate K031448.
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 Digirex TM Digital Dental Radiography System replaces the traditional film approach to x-ray imaging. A digital sensor rather than film is used to capture x-rays from an external source and produce digital images of a patient's mouth. The digital sensor and the USB controller alliow the images to be transferred to a computer for analysis, archiving and electronic transmission.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060640 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060640: Digirex Digital Dental Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060640
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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