510(k) · Cleared
ClearedVistadent at Complete, Model 3.1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentsply Intl., Inc. · LLZ System, Image Processing, Radiological
Cleared on Nov 22, 2005 as substantially equivalent to K043104 (Practiceworks, Inc., 2005) and 2 other predicates after a 27-day review. Its family tree reaches back 4 generations to 1993. 1 later device descends from it.
- Decided
- Nov 22, 2005
- Review
- 27 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K930527 (1993). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK930527 Dental LinkEscan, Inc. · 1993
- 3 generations backK955237 Tigerscan/TigerviewTau Corp. · 1996
- 2 generations backK012439 Dentaleye 2 Dental Image Management SystemRadco Data AB · 2002
- 1 generation backK043104 Kodak Orthodontic Imaging and Oms Imaging 8.0Practiceworks, Inc. · 2005
- This deviceK053010 Vistadent at Complete, Model 3.1Dentsply Intl., Inc. · 2005
- Descendant · cites it directly · 0 of its ownK213263 OnyxCephImage Instruments GmbH · 2023
Most influential descendants
Showing 1 of 1 · See all- K213263OnyxCephImage Instruments GmbH · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K930527 | Dental Link | Escan, Inc. | 1993 | — |
| −3 | K955237 | Tigerscan/Tigerview | Tau Corp. | 1996 | — |
| −2 | K012439 | Dentaleye 2 Dental Image Management System | Radco Data AB | 2002 | — |
| −1 | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0 | Practiceworks, Inc. | 2005 | — |
| 0 (this device) | K053010 | Vistadent at Complete, Model 3.1 | Dentsply Intl., Inc. | 2005 | — |
| +1 | K213263 | OnyxCeph | Image Instruments GmbH | 2023 | — |
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 |
|---|---|---|
| 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 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? (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 |
|---|---|---|---|
| * | K043104 | Kodak Orthodontic Imaging and Oms Imaging 8.0Summary page 1…COMPLETE CLASSIFICATION NAME: Extraoral source x-ray system, 872.1800 PREDICATE DEVICES: KODAK Orthodontic Imaging & OMS Imaging 8.0, K043 104; EagleSoft ChairSide Software Application, K982422; Radco DentalEye 2 D… | 2005 |
| * | K982422 | Eaglesoft ChairsideSummary page 1…tem, 872.1800 PREDICATE DEVICES: KODAK Orthodontic Imaging & OMS Imaging 8.0, K043 104; EagleSoft ChairSide Software Application, K982422; Radco DentalEye 2 Dental Image Management System, K012439 DEVICE DESCRIPTION: VISTADEN~rm AT COM… | 1998 |
| * | K012439 | Dentaleye 2 Dental Image Management SystemSummary page 1…K043 104; EagleSoft ChairSide Software Application, K982422; Radco DentalEye 2 Dental Image Management System, K012439 DEVICE DESCRIPTION: VISTADEN~rm AT COMPLETE software is designed for use as an imaging database for storage and organization o… | 2002 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K213263 | OnyxCeph | 2023 | 0 |
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 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K213263 (Image Instruments GmbH, 2023) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K043104.
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?
VISTADENT m AT COMPLETE software is a digital database for storing, retrieving and printing images that also has the ability to perform image manipulation and cephalometric analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053010 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053010: Vistadent at Complete, Model 3.1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053010
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