510(k) · Cleared
ClearedDental 3D Planning Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Symbyo Dental, LLC · LLZ System, Image Processing, Radiological
Cleared on Dec 6, 2011 as substantially equivalent to K033849 (Materialise NV, 2004) and 1 other predicate after an 18-day review. Its family tree reaches back 5 generations to 1993. 1 later device descends from it.
- Decided
- Dec 6, 2011
- Review
- 18 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K924630 (1993). 6 ancestors in all, the oldest K924810 (1993). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 4 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 3 generations backK033849 Simplant SystemMaterialise NV · 2004
- 2 generations backK061472 Galileos Implant, V 1.0Sicat GmbH & Co. KG · 2006
- 1 generation backK090119 Sicat ImplantSicat GmbH & Co. KG · 2009
- This deviceK113404 Dental 3D Planning SoftwareSymbyo Dental, LLC · 2011
- Descendant · cites it directly · 0 of its ownK173083 Implanter Dental Planning SoftwareImplanter, LLC · 2018
Most influential descendants
Showing 1 of 1 · See all- K173083Implanter Dental Planning SoftwareImplanter, LLC · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −4 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −3 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −2 | K061472 | Galileos Implant, V 1.0 | Sicat GmbH & Co. KG | 2006 | — |
| −1 | K090119 | Sicat Implant | Sicat GmbH & Co. KG | 2009 | — |
| 0 (this device) | K113404 | Dental 3D Planning Software | Symbyo Dental, LLC | 2011 | — |
| +1 | K173083 | Implanter Dental Planning Software | Implanter, LLC | 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 |
|---|---|---|
| 2018 | 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? (2)
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 |
|---|---|---|---|
| * | K033849 | Simplant SystemSummary page 1…050 Panel: Radiology Class 2 Substantial Equivalence claimed to: MATERIALISE N.V. Simplant system (K033849) siCAT GmbH &Co. KG Sicat implant (K090119) Device Description PS is a Dental 3D Plannin… | 2004 |
| * | K090119 | Sicat ImplantSummary page 1…2 Substantial Equivalence claimed to: MATERIALISE N.V. Simplant system (K033849) siCAT GmbH &Co. KG Sicat implant (K090119) Device Description PS is a Dental 3D Planning Software that aids dentists and dental lab technicians in the creation of 3D mode… | 2009 |
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 |
|---|---|---|---|
| K173083 | Implanter Dental Planning Software | 2018 | 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 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K173083 (Implanter, LLC, 2018) has gone furthest, with 0 descendants of its own.
- 19 other devices also cite its predicate K033849.
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?
IFS is prescription use software used by dentists and dental lab technicians for the visualization and image segmentation of DICOM data from medical scanners such as CT. The software aids the user in the creation of 3D models of oral maxillofacial region and in planning dental surgical treatments and placement of dental implants.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K113404 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113404: Dental 3D Planning Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113404
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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