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510(k) Data Aggregation
K Number
K151152Device Name
ImplantMax Software
Manufacturer
Date Cleared
2016-01-12
(257 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SATURN IMAGING INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ImplantMax Software is a stand-alone Windows-based software application to support the diagnosis and treatment planning for dental implantation. It is designed for qualified dental practitioners, including dentists and lab technicians. The software imports the medical image dataset of the patient in DICOM format from medical CT or dental CBCT scanners and transfers the dataset into 3D dataset for pre-operative planning and simulation of dental placement.
The planned implant position can be exported and displayed as the position data of each joint of the articulated arm of ImplantMax Workstation. The user can manually set the position of ImplantMax Workstation arm to match the setting values displayed by ImplantMax Software. ImplantMax Workstation is set to the position to fabricate the surgical template. Please note that ImplantMax Workstation is not part of this 510(k) premarket notification.
The patient population is the general public.
Device Description
ImplantMax is a software interface for the transfer and visualization of 3D medical imaging information from medical CT (computed tomography) or dental CBCT (cone-beam computed tomography) scanner. It is designed to support the diagnosis and treatment planning for dental implantation with the 3D graphic representation. To facilitate the planning, the major software functions are provided as follows.
MPR (multiplanar reconstruction), panoramic, and, 3D image reconstruction (1) for analyzing anatomical condition,
(2) Graphic visualization interface for placing the implant in mandible or maxilla images,
Nerve module for assisting users in distinguishing inferior alveolar nerve (3) (passing through mandibular canal),
Simulation of different sized implants, (4)
(2) Adjustment of implant location, including position and direction,
Alignment function for multiple implants, (6)
Simulation of abutment and crown, (7)
Measurement tools for measuring length and angle, (8)
(ਰ) Bone quality (indicated by CT number) displayed in the area around the implant.
The implant position can be exported and displayed as the joint position of the articulated arm of ImplantMax Workstation that is a separated manually-operated device for fabricating the surgical template.
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