510(k) · Cleared
ClearedKavo Ergocom/Ergocam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kavo America Corporation · LLZ System, Image Processing, Radiological
Cleared on Apr 21, 2005 as substantially equivalent to K012439 (Radco Data AB, 2002) after a 30-day review. Its family tree reaches back 3 generations to 1993. 36 later devices descend from it.
- Decided
- Apr 21, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K930527 (1993). 36 later devices descend from it, 1 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 deviceK050744 Kavo Ergocom/ErgocamKavo America Corporation · 2005
- Descendant · cites it directly · 35 of its ownK060178 Vix Win ProGendex Dental Systems · 2006 · Recalled
- Descendant · 2 generations on · 14 of its ownK141451 VixWin PlatinumImaging Sciences International (Dba Gendex, LLC) · 2014
- Descendant · 2 generations on · 14 of its ownK131594 Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013
- Descendant · 3 generations on · 13 of its ownK162799 CliniviewPalodex Group OY · 2017
- Descendant · 3 generations on · 13 of its ownK150747 EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K060178Vix Win ProGendex Dental Systems · 2006 · cites it directly35descendants
- K141451VixWin PlatinumImaging Sciences International (Dba Gendex, LLC) · 2014 · 2 generations on14descendants
- K131594Ezdenti-I; E2; Prora ViewEwoosoft Co., Ltd. · 2013 · 2 generations on14descendants
- K162799CliniviewPalodex Group OY · 2017 · 3 generations on13descendants
- K150747EzDent-i /E2/Prora ViewLK Consulting Group USA, Inc. · 2015 · 3 generations on13descendants
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) | K050744 | Kavo Ergocom/Ergocam | Kavo America Corporation | 2005 | — |
| +1 | K060178 | Vix Win Pro | Gendex Dental Systems | 2006 | 1 |
| +2 | K141451 | VixWin Platinum | Imaging Sciences International (Dba Gendex, LLC) | 2014 | — |
| +2 | K131594 | Ezdenti-I; E2; Prora View | Ewoosoft Co., Ltd. | 2013 | — |
| +3 | K162799 | Cliniview | Palodex Group OY | 2017 | — |
| +3 | K150747 | EzDent-i /E2/Prora View | LK Consulting Group USA, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K012439 | Dentaleye 2 Dental Image Management SystemSummary page 1…or System, x-ray, extraoral source, digital Product Code MUH Common/Usual Name: Dental Image Management System 2. Equivalent legally marketed device: DentalEye 2, K012439. 3. Indications for Use (intended use): For acquiring, viewing, handling, and storage of dental color images and radiographs.… | 2002 |
What descends from it? (36)
See all 361 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K060178 | Vix Win Pro | 2006 | 35 |
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 3.2 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K060178 (Gendex Dental Systems, 2006) has gone furthest, with 35 descendants of its own.
- 3 other devices also cite its predicate K012439.
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?
For acquiring, viewing, handling, and storage of dental color images and radiographs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050744 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050744: Kavo Ergocom/Ergocam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050744
Report an extraction error
Are you the manufacturer?
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