510(k) · Cleared
ClearedKodak Orthodontic Imaging and Oms Imaging 8.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Practiceworks, Inc. · EHD Unit, X-Ray, Extraoral With Timer
Cleared on Feb 24, 2005 as substantially equivalent to K982422 (Eaglesoft, A Patterson Co., 1998) and 1 other predicate after a 107-day review. Its family tree reaches back 3 generations to 1993. 25 later devices descend from it.
- Decided
- Feb 24, 2005
- Review
- 107 days
- Class
- Class II
- Product code
- EHD
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K930527 (1993). 4 ancestors in all. 25 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK930527 Dental LinkEscan, Inc. · 1993
- 2 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 1 generation backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- This deviceK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- Descendant · cites it directly · 22 of its ownK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- Descendant · 2 generations on · 19 of its ownK131570 OrthovisionEwoosoft Co., Ltd. · 2013
- Descendant · 3 generations on · 18 of its ownK173094 OrthoVisionEwoosoft Co., Ltd. · 2017
- Descendant · 4 generations on · 17 of its ownK192888 EzOrthoEwoosoft Co., Ltd. · 2020
- Descendant · 5 generations on · 6 of its ownK210187 Overjet Dental AssistOverjet, Inc. · 2021
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K122427CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012 · cites it directly22descendants
- K131570OrthovisionEwoosoft Co., Ltd. · 2013 · 2 generations on19descendants
- K173094OrthoVisionEwoosoft Co., Ltd. · 2017 · 3 generations on18descendants
- K192888EzOrthoEwoosoft Co., Ltd. · 2020 · 4 generations on17descendants
- K210187Overjet Dental AssistOverjet, Inc. · 2021 · 5 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −2 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −1 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| 0 (this device) | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| +1 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| +2 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
| +3 | K173094 | OrthoVision | Ewoosoft Co., Ltd. | 2017 | — |
| +4 | K192888 | EzOrtho | Ewoosoft Co., Ltd. | 2020 | — |
| +5 | K210187 | Overjet Dental Assist | Overjet, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (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 |
|---|---|---|---|
| * | K982422 | Eaglesoft ChairsideSummary page 2…software or used as a stand-alone product. 7. Substantial Equivalence Kodak Orthodontic and OMS Imaging 8.0 is substantially equivalent to Chairside (K982422, EagleSoft) and DentalEye (KO12439, Radco Data AB). * Each device is indicated for use in dental or dental sub-s… | 1998 |
| * | K012439 | Dentaleye 2 Dental Image Management System | 2002 |
What descends from it? (25)
See all 252 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 12 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K122427 (Carestream Dental, LLC, 2012) has gone furthest, with 22 descendants of its own.
- 5 other devices also cite its predicate K982422.
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?
Kodak Ortholmaging 8.0 software is indicated for use by orthodontists and their clinical staff in storing and organizing images, including digital photographs and x-rays. The device includes the capability to trace a digital cephalometric radiograph, analyze the measurements taken and make growth or surgical predictions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043104 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043104: Kodak Orthodontic Imaging and Oms Imaging 8.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043104
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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