510(k) · Cleared

Cleared

Sicat Function

K133320510(k) TraditionalCleared Feb 25, 2014120-day reviewClass II21 CFR 892.2050

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Sicat GmbH & Co. KG · LLZ System, Image Processing, Radiological

Cleared on Feb 25, 2014 as substantially equivalent to K103723 (Sicat GmbH & Co. KG, 2011) and 3 other predicates after a 120-day review. Its family tree reaches back 6 generations to 1993. 2 later devices descend from it.

Decided: Feb 25, 2014
Review: 120 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 6 generations to K924630 (1993). 9 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 2 citing it directly.

By dateBy generation

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 deviceK133320 Sicat FunctionSicat GmbH & Co. KG · 2014
Descendant · cites it directly · 0 of its ownK183676 DentiqAir3D Industrial Imaging Co., Ltd. · 2019
Descendant · cites it directly · 0 of its ownK152661 HICAT AirHicat GmbH · 2015

Most influential descendants

Showing 2 of 2 · See all

K183676DentiqAir3D Industrial Imaging Co., Ltd. · 2019 · cites it directly0descendants
K152661HICAT AirHicat GmbH · 2015 · cites it directly0descendants

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)	K133320	Sicat Function	Sicat GmbH & Co. KG	2014	—
+1	K183676	DentiqAir	3D Industrial Imaging Co., Ltd.	2019	—
+1	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
2015	1	0
2019	1	0

FIG. 1 — Lineage of K133320, 1993–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K103723	Sicat Implant V1.2 Summary page 1 …LLZ Regulation Number: 21 CFR 892.2050 Classification Class: Class II Product 3. PREDICATE DEVICES * SICAT Implant (K103723) * Materialise SimPlant V 12.0 with OMS Module (K033849, K053592, K081402) 4. DEVICE DESCRIPTION SICAT Function is…	Sicat GmbH & Co. KG	2011	—
*	K033849	Simplant System Summary page 1 …Classification Class: Class II Product 3. PREDICATE DEVICES * SICAT Implant (K103723) * Materialise SimPlant V 12.0 with OMS Module (K033849, K053592, K081402) 4. DEVICE DESCRIPTION SICAT Function is a pure software device. SICAT Function is a software appli…	Materialise NV	2004	—
*	K053592	Simplant DR. James Summary page 1 …fication Class: Class II Product 3. PREDICATE DEVICES * SICAT Implant (K103723) * Materialise SimPlant V 12.0 with OMS Module (K033849, K053592, K081402) 4. DEVICE DESCRIPTION SICAT Function is a pure software device. SICAT Function is a software application fo…	Materialise NV	2006	—
*	K081402	Simplant Ortho ; Vistadent 3D Summary page 1 …Class: Class II Product 3. PREDICATE DEVICES * SICAT Implant (K103723) * Materialise SimPlant V 12.0 with OMS Module (K033849, K053592, K081402) 4. DEVICE DESCRIPTION SICAT Function is a pure software device. SICAT Function is a software application for the vis…	Materialise Dental NV	2008	—

Also cleared against K103723: 2 other devices →

What descends from it? (2)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K183676	DentiqAir	3D Industrial Imaging Co., Ltd.	2019	0
K152661	HICAT Air	Hicat GmbH	2015	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 21 years and passes through 4 companies; a new generation was cleared every 2.8 years on median.
None of the 9 ancestors has a recall.
Of its descendants, K183676 (3D Industrial Imaging Co., Ltd., 2019) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K103723.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)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 Function is a software application for the visualization and segmentation of imaging information of the oral-maxillofacial region. The imaging data originates from medical scanners such as CT or CUCT scanners. It is also used as a software system to aid qualified dental professionals with the evaluation of dental treatment options. The dental professionals' planning data may be exported from SICAT Function and used as input data for CAD or Rapid Prototyping Systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K133320 · printed Nov 6, 2026

Cite this page

510(k) Report. “K133320: Sicat Function.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133320

Report an extraction error

Are you the manufacturer?

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