510(k) · Cleared

Cleared

Galileos Implant, Version 1.7

K093090510(k) TraditionalCleared Dec 17, 200977-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 Dec 17, 2009 as substantially equivalent to K033849 (Materialise NV, 2004) and 3 other predicates after a 77-day review. Its family tree reaches back 5 generations to 1993.

Decided: Dec 17, 2009
Review: 77 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 4

Its longest line of descent runs back 5 generations to K924630 (1993). 7 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.

By dateBy generation

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 deviceK093090 Galileos Implant, Version 1.7Sicat GmbH & Co. KG · 2009

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)	K093090	Galileos Implant, Version 1.7	Sicat GmbH & Co. KG	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
2006	1	0

FIG. 1 — Lineage of K093090, 1993–2009Source: 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

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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
*	K033849	Simplant System Summary page 2 …ALILEOS Implant Vi .7 isclaimed to be substantially equivalent in material, design and function to the SimPlant 12 product which was cleared by FDA under 510O(k) K033849 (May 25, 2004), K053592 (Feb 8,2006), K081402 (JUL 18,2008) and the GALILEOS Implant V1.0 product which was clear…	Materialise NV	2004	—
*	K053592	Simplant DR. James Summary page 2 …to be substantially equivalent in material, design and function to the SimPlant 12 product which was cleared by FDA under 510O(k) K033849 (May 25, 2004), K053592 (Feb 8,2006), K081402 (JUL 18,2008) and the GALILEOS Implant V1.0 product which was cleared by FDA under 510(k) K06 1472…	Materialise NV	2006	—
*	K081402	Simplant Ortho ; Vistadent 3D Summary page 2 …uivalent in material, design and function to the SimPlant 12 product which was cleared by FDA under 510O(k) K033849 (May 25, 2004), K053592 (Feb 8,2006), K081402 (JUL 18,2008) and the GALILEOS Implant V1.0 product which was cleared by FDA under 510(k) K06 1472 on June 9,2006. 4…	Materialise Dental NV	2008	—
*	K061472	Galileos Implant, V 1.0 Summary page 2 …r 510O(k) K033849 (May 25, 2004), K053592 (Feb 8,2006), K081402 (JUL 18,2008) and the GALILEOS Implant V1.0 product which was cleared by FDA under 510(k) K06 1472 on June 9,2006. 4 Device Description GALILEOS Implant Vi .7 isa pure software device. GALlILEOS Implant…	Sicat GmbH & Co. KG	2006	—

Also cleared against K033849: 19 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 16 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
None of the 7 ancestors has a recall.
19 other devices also cite its predicate K033849.

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. 2009, 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?

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. GALILEOS Implant is based on medical imaging information presented by the Sirona GALAXIS 3D viewer and produced by Sirona GALILEOS medical cone beam scanner. The dental professionals' input information may be exported from GALILEOS Implant and used as input data for CAD (Computer-Aided Design) or Rapid Prototyping Systems.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K093090 · printed Nov 4, 2026

Cite this page

510(k) Report. “K093090: Galileos Implant, Version 1.7.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093090

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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