510(k) · Cleared
ClearedDentaleye 2 Dental Image Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radco Data AB · LLZ System, Image Processing, Radiological
Cleared on Feb 6, 2002 as substantially equivalent to K955237 (Tau Corp., 1996) after a 190-day review. Its family tree reaches back 2 generations to 1993. 63 later devices descend from it.
- Decided
- Feb 6, 2002
- Review
- 190 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K930527 (1993). 63 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK930527 Dental LinkEscan, Inc. · 1993
- 1 generation backK955237 Tigerscan/TigerviewTau Corp. · 1996
- This deviceK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- Descendant · cites it directly · 36 of its ownK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- Descendant · cites it directly · 35 of its ownK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- Descendant · cites it directly · 25 of its ownK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- Descendant · 2 generations on · 22 of its ownK122427 CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012
- Descendant · 3 generations on · 19 of its ownK131570 OrthovisionEwoosoft Co., Ltd. · 2013
Showing 5 of 63 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 63 · See all- K050744Kavo Ergocom/ErgocamKavo America Corporation · 2005 · cites it directly36descendants
- K060178Vix Win ProGendex Dental Systems · 2006 · cites it directly35descendants
- K043104Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005 · cites it directly25descendants
- K122427CS Orthodontic Imaging Software CS Oms Imaging SoftwareCarestream Dental, LLC · 2012 · 2 generations on22descendants
- K131570OrthovisionEwoosoft Co., Ltd. · 2013 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −1 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| 0 (this device) | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| +1 | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| +1 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| +1 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| +2 | K122427 | CS Orthodontic Imaging Software CS Oms Imaging Software | Carestream Dental, LLC | 2012 | — |
| +3 | K131570 | Orthovision | Ewoosoft Co., Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 5 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 LLZ? 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 LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 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 |
|---|---|---|---|
| * | K955237 | Tigerscan/TigerviewSummary page 1…mmon/Usual Name: Dental Image Management System 2. Equivalent legally marketed device: This product is similar in design and identical in function to the TAU TigerView, K955237 3. Indications for Use (intended use): Indicated for acquisition, storage, display, and manipulation of Dental Images 4. Descri… | 1996 |
What descends from it? (63)
See all 634 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 9 years and passes through 3 companies; a new generation was cleared every 5.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K050744 (Kavo America Corporation, 2005) has gone furthest, with 36 descendants of its own.
- 5 other devices also cite its predicate K955237.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, 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 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Intended Uses for DentalEye 2 in the dental industry are as follows
Acquiring and handling of dental radiographs and color images
Viewing and manipulation for insurance claims adjudication
Viewing and manipulation for diagnostic purposes
Viewing for patient education and consultation including cosmetic imaging.
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/K012439 · printed Nov 6, 2026
Cite this page
510(k) Report. “K012439: Dentaleye 2 Dental Image Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K012439
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026