510(k) · Cleared
ClearedSimplant Ortho ; Vistadent 3D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Materialise Dental NV · LLZ System, Image Processing, Radiological
Cleared on Jul 18, 2008 as substantially equivalent to K053592 (Materialise NV, 2006) after a 60-day review. Its family tree reaches back 4 generations to 1993. 7 later devices descend from it.
- Decided
- Jul 18, 2008
- Review
- 60 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K924630 (1993). 5 ancestors in all, the oldest K924810 (1993). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 3 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 2 generations backK033849 Simplant SystemMaterialise NV · 2004
- 1 generation backK053592 Simplant DR. JamesMaterialise NV · 2006
- This deviceK081402 Simplant Ortho ; Vistadent 3DMaterialise Dental NV · 2008
- Descendant · cites it directly · 5 of its ownK103723 Sicat Implant V1.2Sicat GmbH & Co. KG · 2011
- Descendant · cites it directly · 2 of its ownK133320 Sicat FunctionSicat GmbH & Co. KG · 2014
- Descendant · 2 generations on · 0 of its ownK183676 DentiqAir3D Industrial Imaging Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK192348 SICAT Implant V2.0Sicat GmbH & Co. KG · 2019 · Recalled
- Descendant · 2 generations on · 0 of its ownK180262 SICAT EndoSicat GmbH & Co. KG · 2018
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K103723Sicat Implant V1.2Sicat GmbH & Co. KG · 2011 · cites it directly5descendants
- K133320Sicat FunctionSicat GmbH & Co. KG · 2014 · cites it directly2descendants
- K183676DentiqAir3D Industrial Imaging Co., Ltd. · 2019 · 2 generations on0descendants
- K192348SICAT Implant V2.0Sicat GmbH & Co. KG · 2019 · 2 generations on0descendants
- K180262SICAT EndoSicat GmbH & Co. KG · 2018 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −3 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −2 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −1 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| 0 (this device) | K081402 | Simplant Ortho ; Vistadent 3D | Materialise Dental NV | 2008 | — |
| +1 | K103723 | Sicat Implant V1.2 | Sicat GmbH & Co. KG | 2011 | — |
| +1 | K133320 | Sicat Function | Sicat GmbH & Co. KG | 2014 | — |
| +2 | K183676 | DentiqAir | 3D Industrial Imaging Co., Ltd. | 2019 | — |
| +2 | K192348 | SICAT Implant V2.0 | Sicat GmbH & Co. KG | 2019 | 1 |
| +2 | K180262 | SICAT Endo | Sicat GmbH & Co. KG | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 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 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 |
|---|---|---|---|
| * | K053592 | Simplant DR. JamesSummary page 1…ng (C.F.R. Section 892.2050, Product code: LLZ) PREDICATE DEVICE SimPlant System; SimPlant Dr. James (K053592) FUNCTION Simplant Ortho provides a method of segmenting CT images. This file allows the individual patient's CT image to be ass… | 2006 |
What descends from it? (7)
3 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 15 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103723 (Sicat GmbH & Co. KG, 2011) has gone furthest, with 5 descendants of its own.
- 6 other devices also cite its predicate K053592.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Materialise Dental's SimPlant Ortho; Vistadent 3D software is indicated for use as a medical front-end software that can be used by medically trained people for the purpose of visualizing gray value images. It is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CT scanner or a Magnetic Resonance scanner. It is also used as a software system for simulating/evaluating orthodontic treatment i.e. dental bite options.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081402 · printed Nov 4, 2026
Cite this page
510(k) Report. “K081402: Simplant Ortho ; Vistadent 3D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K081402
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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