# K253902: RealGUIDE

- Pathway: 510(k) (Traditional)
- Applicant: 3DIEMME SRL
- Decided: Aug 4, 2026 after 242 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K954678 (1996). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173041: 3DIEMME RealGUIDE, 3Diemme, Ltd. (2018) Summary page 5.
- K152078: Implant Studio 2015, 3Shape Medical A/S (2015) Summary page 9.

## Indications for use
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.

Source page: https://510kreport.com/device/K253902
Methodology: https://510kreport.com/methodology