510(k) · Cleared
Recalled · Class II · 2020SICAT Implant V2.0
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 Dec 4, 2019 as substantially equivalent to K103723 (Sicat GmbH & Co. KG, 2011) after a 97-day review. Its family tree reaches back 6 generations to 1993. It has been recalled once.
- Decided
- Dec 4, 2019
- Review
- 97 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 6 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 6 generations backK924630 Surgicad (TM) View (TM)Surgicad Corp. · 1993
- 5 generations backK970617 CT-Modeller SystemMaterialise NV · 1997
- 4 generations backK033849 Simplant SystemMaterialise NV · 2004
- 3 generations backK053592 Simplant DR. JamesMaterialise NV · 2006
- 2 generations backK081402 Simplant Ortho ; Vistadent 3DMaterialise Dental NV · 2008
- 1 generation backK103723 Sicat Implant V1.2Sicat GmbH & Co. KG · 2011
- This deviceK192348 SICAT Implant V2.0Sicat GmbH & Co. KG · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K924630 | Surgicad (TM) View (TM) | Surgicad Corp. | 1993 | — |
| −5 | K970617 | CT-Modeller System | Materialise NV | 1997 | — |
| −4 | K033849 | Simplant System | Materialise NV | 2004 | — |
| −3 | K053592 | Simplant DR. James | Materialise NV | 2006 | — |
| −2 | K081402 | Simplant Ortho ; Vistadent 3D | Materialise Dental NV | 2008 | — |
| −1 | K103723 | Sicat Implant V1.2 | Sicat GmbH & Co. KG | 2011 | — |
| 0 (this device) | K192348 | SICAT Implant V2.0 | Sicat GmbH & Co. KG | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K103723 | Sicat Implant V1.2Summary page 4…II 3. PREDICATE DEVICE Proprietary Name: SICAT Implant V1.2 Manufacturer: SICAT GmbH & Co. KG 510(k) number: K103723 4. DEVICE DESCRIPTION SICAT Implant V2.0 is a pure software device. SICAT GmbH & Co., Traditional 510(k) Dec… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 15, 2020 | Class II | Z-2951-2020 | Software design | A dentist found implant positions are not correctly exported from the implant planning software SICAT IMPLANT V2.0 - for the specific export format CMG.DXD. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- None of the 9 ancestors has a recall.
- 2 other devices also cite its predicate K103723.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
SICAT Implant 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 CBCT scanners. SICAT Implant is intended for use as planning software to aid qualified dental professionals in the placement of dental implants and the planning of surgical treatments. The dental professionals' planning data can be exported from SICAT Implant. This planning data includes in particular the positions, orientations and types of implants and drill sleeves to be used in the surgical procedures. This data may be used as input to design and manufacture surgical guides for dental implants.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K192348 · printed Nov 6, 2026
Cite this page
510(k) Report. “K192348: SICAT Implant V2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K192348
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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