510(k) · Cleared
Cleared3DIEMME RealGUIDE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Diemme, Ltd. · LLZ System, Image Processing, Radiological
Cleared on Dec 20, 2018 as substantially equivalent to K152078 (3Shape Medical A/S, 2015) after a 448-day review. Its family tree reaches back 9 generations to 1996. 2 later devices descend from it.
- Decided
- Dec 20, 2018
- Review
- 448 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K954678 (1996). 15 ancestors in all, the oldest K924810 (1993). 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 5 generations between
- 3 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 2 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 1 generation backK152078 Implant Studio 20153Shape Medical A/S · 2015
- This deviceK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
- Descendant · cites it directly · 0 of its ownK253902 RealGUIDE3DIEMME SRL · 2026
- Descendant · cites it directly · 0 of its ownK203765 ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice…Zirkonzahn Srl · 2021
Show all 9 generations
- Root · 9 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 8 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 7 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 6 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 5 generations backK053155 VimplantCybermed, Inc. · 2005
- 4 generations backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 3 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 2 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 1 generation backK152078 Implant Studio 20153Shape Medical A/S · 2015
- This deviceK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −8 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −7 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −6 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −5 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −4 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −3 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| −2 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| −1 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| 0 (this device) | K173041 | 3DIEMME RealGUIDE | 3Diemme, Ltd. | 2018 | — |
| +1 | K253902 | RealGUIDE | 3DIEMME SRL | 2026 | — |
| +1 | K203765 | ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL… | Zirkonzahn Srl | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 2 | 0 |
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K152078 | Implant Studio 2015Summary page 5…There have been no prior submissions for the subject device. 3 Predicate device Name of Device: Implant StudioTM 2015-1 Manufacturer: 3Shape Medical A/S K Number: K152078 Product Code: LLZ This predicate device has not been subject to a design-related recall. Reference Device #1: Name of Device: S… | 2015 |
| † | K110300 | Simplant 2011 | 2011 |
| † | K130724 | Codiagnostix Implant Planning Software | 2013 |
| † | K130242 | Maven Pro | 2013 |
What descends from it? (2)
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 22 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K253902 (3DIEMME SRL, 2026) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K152078.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
PC/MAC version: The RealGUIDE software is intended for the following uses: 1. Support to the diagnosis for trained professionals. The input DICOM files acquired by a CT/CBCT scanner are not modified in any way but they are showed to the doctor through the classical imaging and volume rendering techniques. It is a stand-alone product. No information of the patient is modified, all the parameters used for the image processing are read from the DICOM file…
Read the full statement (404 words)
PC/MAC version:
The RealGUIDE software is intended for the following uses:
1. Support to the diagnosis for trained professionals. The input DICOM files acquired by a CT/CBCT scanner are not modified in any way but they are showed to the doctor through the classical imaging and volume rendering techniques. It is a stand-alone product. No information of the patient is modified, all the parameters used for the image processing are read from the DICOM file itself. Neither automatic diagnosis is made, nor automatic disease detection is performed. This software is not connected to any medical instrumentation and it doesn’t control any medical or energy supplying device. The user imports DICOM data coming from any CT/CBCT imaging device and the software enables him to view the Patient exam in different multi-planar 2D images and easily reconstruct the 3D volume for an immediate visualization of bone structures and surrounding tissues.
2. Virtual oral and maxillofacial surgery planning. Doctors can plan virtual implants and surgeries on 2D/3D reconstructions and export the projects in open or proprietary format for further processing. The user can choose different implant models (for example dental implants models) from a library provided by the Manufacturers and simulate the positioning in the Patient reconstructed volume (this operation is called “virtual plan”)
3. Dental/maxillofacial surgical guides and prosthetic modelling. The virtual plan is used to design a surgical guide that is used by the doctor to drive the surgery drills according to the planned implants direction and depth. This surgical guide can be manufactured by any 3D printer working from STL files. The user can also design the patient prosthesis (typically a denture) with the surface and volume free-form tools implemented in the software. The result is exported in STL format for 3D printing or CAD/CAM technologies.
Mobile version:
The RealGUIDE software APP is intended for the following uses:
1. Projects visualization and editing. The input PROJECT files, pre-processed with the RealGUIDE desktop version, are used by trained professionals to evaluate the implants projects, edit them and share them with other colleagues through the cloud, as well as for a more effective Patient treatment communication.
The RealGUIDE APP version is NOT INTENDED for managing a 3D diagnosis starting from DICOM images, due to the mobile devices screen resolution limitations. For this reason, the APP is not reading directly the DICOM files but only pre-processed project files, exported through the cloud by the RealGUIDE desktop version.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173041 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173041: 3DIEMME RealGUIDE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173041
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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