510(k) · Cleared
ClearedGalileos Implant, V 1.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sicat GmbH & Co. KG · LLZ System, Image Processing, Radiological
Cleared on Jun 9, 2006 as substantially equivalent to K033849 (Materialise NV, 2004) after a 10-day review. Its family tree reaches back 3 generations to 1993. 10 later devices descend from it.
- Decided
- Jun 9, 2006
- Review
- 10 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K924630 (1993). 4 ancestors in all, the oldest K924810 (1993). 10 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 2 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 1 generation backK033849 Simplant SystemMaterialise NV · 2004
- This deviceK061472 Galileos Implant, V 1.0Sicat GmbH & Co. KG · 2006
- Descendant · cites it directly · 8 of its ownK090119 Sicat ImplantSicat GmbH & Co. KG · 2009
- Descendant · 2 generations on · 5 of its ownK103723 Sicat Implant V1.2Sicat GmbH & Co. KG · 2011
- Descendant · 3 generations on · 2 of its ownK133320 Sicat FunctionSicat GmbH & Co. KG · 2014
- Descendant · 2 generations on · 1 of its ownK113404 Dental 3D Planning SoftwareSymbyo Dental, LLC · 2011
- Descendant · 4 generations on · 0 of its ownK183676 DentiqAir3D Industrial Imaging Co., Ltd. · 2019
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K090119Sicat ImplantSicat GmbH & Co. KG · 2009 · cites it directly8descendants
- K103723Sicat Implant V1.2Sicat GmbH & Co. KG · 2011 · 2 generations on5descendants
- K133320Sicat FunctionSicat GmbH & Co. KG · 2014 · 3 generations on2descendants
- K113404Dental 3D Planning SoftwareSymbyo Dental, LLC · 2011 · 2 generations on1descendant
- K183676DentiqAir3D Industrial Imaging Co., Ltd. · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −2 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −1 | K033849 | Simplant System | Materialise NV | 2004 | — |
| 0 (this device) | K061472 | Galileos Implant, V 1.0 | Sicat GmbH & Co. KG | 2006 | — |
| +1 | K090119 | Sicat Implant | Sicat GmbH & Co. KG | 2009 | — |
| +2 | K103723 | Sicat Implant V1.2 | Sicat GmbH & Co. KG | 2011 | — |
| +3 | K133320 | Sicat Function | Sicat GmbH & Co. KG | 2014 | — |
| +2 | K113404 | Dental 3D Planning Software | Symbyo Dental, LLC | 2011 | — |
| +4 | K183676 | DentiqAir | 3D Industrial Imaging Co., Ltd. | 2019 | — |
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 | 2 | 0 |
| 2011 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 2 | 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 |
|---|---|---|---|
| * | K033849 | Simplant SystemSummary page 1…GALILEOS Implant is claimed to be substantially equivalent in material, design and function to the SimPlant System product which was cleared by FDA under 510(k) K033849 on May 25, 2004. siCAT GmbH & Co. KG 510(k) May 12th, 2006 4 Device Clas… | 2004 |
What descends from it? (10)
2 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 13 years and passes through 3 companies; a new generation was cleared every 4.0 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K090119 (Sicat GmbH & Co. KG, 2009) has gone furthest, with 8 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.
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?
GALILEOS Implant is intended for use as planning and simulation software to aid qualified dental professionals in the placement of dental implants and the planning of surgical implant treatments. GALLEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALULEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD or Rapid Prototyping Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061472 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061472: Galileos Implant, V 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061472
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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