510(k) · Cleared
ClearedSimplant 2011
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 1, 2011 as substantially equivalent to K053592 (Materialise NV, 2006) after a 149-day review. Its family tree reaches back 4 generations to 1993. 20 later devices descend from it.
- Decided
- Jul 1, 2011
- Review
- 149 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). 20 later devices descend from it, 9 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 deviceK110300 Simplant 2011Materialise Dental NV · 2011
- Descendant · cites it directly · 8 of its ownK141570 Implant Studio3Shape Medical A/S · 2014
- Descendant · cites it directly · 7 of its ownK152078 Implant Studio 20153Shape Medical A/S · 2015
- Descendant · cites it directly · 3 of its ownK113739 Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012
- Descendant · 2 generations on · 2 of its ownK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
- Descendant · 2 generations on · 2 of its ownK170849 SIMPLANT GuideDentsply Sirona · 2017
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K141570Implant Studio3Shape Medical A/S · 2014 · cites it directly8descendants
- K152078Implant Studio 20153Shape Medical A/S · 2015 · cites it directly7descendants
- K113739Simplant Immediate Smile Dental Care SystemMaterialise Dental NV · 2012 · cites it directly3descendants
- K1730413DIEMME RealGUIDE3Diemme, Ltd. · 2018 · 2 generations on2descendants
- K170849SIMPLANT GuideDentsply Sirona · 2017 · 2 generations on2descendants
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) | K110300 | Simplant 2011 | Materialise Dental NV | 2011 | — |
| +1 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| +1 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| +1 | K113739 | Simplant Immediate Smile Dental Care System | Materialise Dental NV | 2012 | — |
| +2 | K173041 | 3DIEMME RealGUIDE | 3Diemme, Ltd. | 2018 | — |
| +2 | K170849 | SIMPLANT Guide | Dentsply Sirona | 2017 | — |
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 |
|---|---|---|
| 2012 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2026 | 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? (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…NAME: System, Image Processing. This product uses images acquired from Computerized Tomography (CT) scanners. PREDICATE DEVICE SimPlant Or James (K053592) FUNCTION The modified SimPlant System is used to transfer images from a medical scanner and to perform a segmentation of the i… | 2006 |
What descends from it? (20)
See all 209 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141570 | Implant Studio | 2014 | 8 |
| K152078 | Implant Studio 2015 | 2015 | 7 |
| K113739 | Simplant Immediate Smile Dental Care System | 2012 | 3 |
| K171115 | 3D Endo Software | 2017 | 1 |
| K172239 | Simplant 18 | 2018 | 0 |
| K161118 | SIMPLANT Online Case Review and SIMPLANT Editor | 2016 | 0 |
| K153091 | Implant 3D | 2016 | 0 |
| K120733 | Simplant GO | 2012 | 0 |
| K112679 | Simplant Navigator Personalized Dental Care System | 2012 | 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 18 years and passes through 3 companies; a new generation was cleared every 5.4 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K141570 (3Shape Medical A/S, 2014) has gone furthest, with 8 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. 2011, 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?
SimPlant 2011 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 intended as pre-planning software for dental implant placement and surgical treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110300 · printed Nov 6, 2026
Cite this page
510(k) Report. “K110300: Simplant 2011.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K110300
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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