510(k) · Cleared
ClearedSicat Implant V1.2
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 May 20, 2011 as substantially equivalent to K090119 (Sicat GmbH & Co. KG, 2009) and 3 other predicates after a 150-day review. Its family tree reaches back 5 generations to 1993. 5 later devices descend from it.
- Decided
- May 20, 2011
- Review
- 150 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K924630 (1993). 8 ancestors in all, the oldest K924810 (1993). 5 later devices descend from it, 3 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 backK053592 Simplant DR. JamesMaterialise NV · 2006
- 1 generation backK081402 Simplant Ortho ; Vistadent 3DMaterialise Dental NV · 2008
- This deviceK103723 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 · cites it directly · 0 of its ownK192348 SICAT Implant V2.0Sicat GmbH & Co. KG · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK180262 SICAT EndoSicat GmbH & Co. KG · 2018
- Descendant · 2 generations on · 0 of its ownK152661 HICAT AirHicat GmbH · 2015
Most influential descendants
Showing 5 of 5 · See all- 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 · cites it directly0descendants
- K180262SICAT EndoSicat GmbH & Co. KG · 2018 · cites it directly0descendants
- K152661HICAT AirHicat GmbH · 2015 · 2 generations on0descendants
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 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| −1 | K081402 | Simplant Ortho ; Vistadent 3D | Materialise Dental NV | 2008 | — |
| 0 (this device) | 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 | — |
| +1 | K192348 | SICAT Implant V2.0 | Sicat GmbH & Co. KG | 2019 | 1 |
| +1 | K180262 | SICAT Endo | Sicat GmbH & Co. KG | 2018 | — |
| +2 | K152661 | HICAT Air | Hicat GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (4)
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 |
|---|---|---|---|
| * | K090119 | Sicat ImplantSummary page 1…LLZ Regulation Number: 892.2050 Classification Class: Class 11 Product 3. PREDICATE DEVICES " SICAT Implant (V 1.0 incl. SPI), K0901 19 * Materialise SimPlant V 12.0 with OMS Module, K033849, K053592, K08 1402 4. DEVICE DESCRIPTION SICAT Implant VI.2 is a pure… | 2009 |
| * | K033849 | Simplant SystemSummary page 1…050 Classification Class: Class 11 Product 3. PREDICATE DEVICES " SICAT Implant (V 1.0 incl. SPI), K0901 19 * Materialise SimPlant V 12.0 with OMS Module, K033849, K053592, K08 1402 4. DEVICE DESCRIPTION SICAT Implant VI.2 is a pure software device. SICAT Implant Vl.2 is a software appl… | 2004 |
| * | K053592 | Simplant DR. JamesSummary page 1…ssification Class: Class 11 Product 3. PREDICATE DEVICES " SICAT Implant (V 1.0 incl. SPI), K0901 19 * Materialise SimPlant V 12.0 with OMS Module, K033849, K053592, K08 1402 4. DEVICE DESCRIPTION SICAT Implant VI.2 is a pure software device. SICAT Implant Vl.2 is a software application f… | 2006 |
| * | K081402 | Simplant Ortho ; Vistadent 3DSummary page 1…on Class: Class 11 Product 3. PREDICATE DEVICES " SICAT Implant (V 1.0 incl. SPI), K0901 19 * Materialise SimPlant V 12.0 with OMS Module, K033849, K053592, K08 1402 4. DEVICE DESCRIPTION SICAT Implant VI.2 is a pure software device. SICAT Implant Vl.2 is a software application for the vis… | 2008 |
What descends from it? (5)
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 18 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K133320 (Sicat GmbH & Co. KG, 2014) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K090119.
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?
The SICAT Implant V 1.2 is a software application for the visualization of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or OWE scanners. The SICAT Implant V 1.2 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 treatments. The dental professionals' planning data may be exported from SICAT Implant V 1.2 and used as input data for CAD or Rapid Prototyping Systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103723 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103723: Sicat Implant V1.2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103723
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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