CDSCO UID IMP/MD/2023/000540_c41e381dae2e214d230d11667bf76a52_28b87d682513e578be0faef91104d9bd

RealGUIDE Software Suite

ZB DENTAL INDIA PRIVATE LIMITED·Device Class Class B·India CDSCO

Registration details

UID: IMP/MD/2023/000540_c41e381dae2e214d230d11667bf76a52_28b87d682513e578be0faef91104d9bd
Device class: Class B
License holder: ZB DENTAL INDIA PRIVATE LIMITED
Approving authority: CDSCO
Product information: The device is a software to be used in the dental field by trained professionals to support diagnosis, to plan virtual implants and surgeries on 2D/3D reconstructions, to design surgical guides and prosthetic modelling, and manage the endodontic, orthodontic and orthognathic treatments connected to the oral and maxilla-facial rehabilitations. 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/MRI 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/MR 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 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 (N/A) from a library provided by the Manufacturers and simulate the positioning in the Patient reconstructed volume (this operation is called “virtual plan” 3. 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 (N/A) 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.

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About this record

RealGUIDE Software Suite is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID IMP/MD/2023/000540_c41e381dae2e214d230d11667bf76a52_28b87d682513e578be0faef91104d9bd. The license holder is ZB DENTAL INDIA PRIVATE LIMITED, and it is classified as Device Class Class B. The approving authority is CDSCO.

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