510(k) · Cleared
ClearedRealGUIDE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3DIEMME SRL · QIH Automated Radiological Image Processing Software
Cleared on Aug 4, 2026 as substantially equivalent to K173041 (3Diemme, Ltd., 2018) and 1 other predicate after a 242-day review. Its family tree reaches back 10 generations to 1996.
- Decided
- Aug 4, 2026
- Review
- 242 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K954678 (1996). 16 ancestors in all, the oldest K924810 (1993). No later device cites it as a predicate yet.
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 6 generations between
- 3 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 2 generations backK152078 Implant Studio 20153Shape Medical A/S · 2015
- 1 generation backK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
- This deviceK253902 RealGUIDE3DIEMME SRL · 2026
Show all 10 generations
- Root · 10 generations backK954678 Pro VisionAlgotec Systems, Ltd. · 1996
- 9 generations backK980648 Pro VisionAlgotec Systems, Ltd. · 1998
- 8 generations backK992654 Plug 'N View 3D, Version 1.0Voxar Limited · 1999
- 7 generations backK013878 Cybermed, Inc., V-WorksCybermed, Inc. · 2001
- 6 generations backK053155 VimplantCybermed, Inc. · 2005
- 5 generations backK071636 Codiagnostix (R) 5.72Ivs Solutions AG · 2007 · Recalled
- 4 generations backK130724 Codiagnostix Implant Planning SoftwareStraumann USA · 2013
- 3 generations backK141570 Implant Studio3Shape Medical A/S · 2014
- 2 generations backK152078 Implant Studio 20153Shape Medical A/S · 2015
- 1 generation backK173041 3DIEMME RealGUIDE3Diemme, Ltd. · 2018
- This deviceK253902 RealGUIDE3DIEMME SRL · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K954678 | Pro Vision | Algotec Systems, Ltd. | 1996 | — |
| −9 | K980648 | Pro Vision | Algotec Systems, Ltd. | 1998 | — |
| −8 | K992654 | Plug 'N View 3D, Version 1.0 | Voxar Limited | 1999 | — |
| −7 | K013878 | Cybermed, Inc., V-Works | Cybermed, Inc. | 2001 | — |
| −6 | K053155 | Vimplant | Cybermed, Inc. | 2005 | — |
| −5 | K071636 | Codiagnostix (R) 5.72 | Ivs Solutions AG | 2007 | 2 |
| −4 | K130724 | Codiagnostix Implant Planning Software | Straumann USA | 2013 | — |
| −3 | K141570 | Implant Studio | 3Shape Medical A/S | 2014 | — |
| −2 | K152078 | Implant Studio 2015 | 3Shape Medical A/S | 2015 | — |
| −1 | K173041 | 3DIEMME RealGUIDE | 3Diemme, Ltd. | 2018 | — |
| 0 (this device) | K253902 | RealGUIDE | 3DIEMME SRL | 2026 | — |
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 |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.6 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K173041 | 3DIEMME RealGUIDESummary page 5…e Regulation: 892.2050 Primary Product Code: QIH Additional Product Code(s): LLZ 3 Predicate device Name of Device: 3Diemme RealGUIDE Manufacturer: 3Diemme K Number: K173041 Product Code: LLZ Reference Device #1: Name of Device: Relu Creator Manufacturer: Relu BV K Number: K233925 Product Code: QIH… | 2018 |
| * | K152078 | Implant Studio 2015Summary page 9…ion date: 30/07/2026 Pag. 5 of 5 The software under evaluation is the subsequent update of the previously marketed version of RealGUIDE (K152078), being considered as predicate device. Testing demonstrates the implemented functions perform as intended, and differences betw… | 2015 |
| † | K233925 | Relu Creator | 2024 |
| † | K230012 | Atomica Planner | 2023 |
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 30 years and passes through 8 companies; a new generation was cleared every 2.5 years on median.
- 1 of the 16 ancestors has a recall of any class.
- 1 other device also cites its predicate K173041.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
What is it indicated for?
RealGUIDE is a stand-alone software indicated for the preparation of patient specific treatment planning by professional user and, in particular, it must be used by dental clinician, general practitioner (DDS) dentist, or specialist such as, a Periodontist or Oral Surgeon. The software is indicated for use on patients that require dental implant placement planning, prosthesis modelling and endodontic treatments connected to the endosseous dental implant…
Read the full statement (221 words)
RealGUIDE is a stand-alone software indicated for the preparation of patient specific treatment planning by professional user and, in particular, it must be used by dental clinician, general practitioner (DDS) dentist, or specialist such as, a Periodontist or Oral Surgeon. The software is indicated for use on patients that require dental implant placement planning, prosthesis modelling and endodontic treatments connected to the endosseous dental implant placement. RealGUIDE is, in further detail, indicated for:
- Viewing in 2D/3D patient images and processing them (DICOM or STL), including volume editing and measurement
- Segmenting bone, nerve canal and teeth
- Virtually positioning dental implants
- Designing templates for endosseous dental implant guided placement
- Modelling reconstructive devices, such as bone grafts and grids
- Designing dental prosthetics, such as crown, bridges and dentures
- Saving dental surgery template’s or prostheses’ design to file
RealGUIDE software allows for endosseous dental implant surgical guide and prosthetic component file creation (*.STL) for the user to further process with specific CAD systems before export to validated manufacturing centers or to the point of care. Manufacturing at the point of care requires a validated process using CAM equipment (additive manufacturing system, including software and associated tooling) and compatible material (biocompatible and sterilizable).
The software is not intended to perform automatic diagnosis and to control the manufacture of devices.
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/K253902 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253902: RealGUIDE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253902
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026