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510(k) Data Aggregation
K Number
K153091Device Name
IMPLANT 3D
Manufacturer
Date Cleared
2016-02-25
(122 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Media Lab S.r.l.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Implant 3D is intended for use as a software interface and image segmentation system for the transfer of imaging information from a medical scanner such as a CAT scanner. It is also intended as pre-planning software for dental implant placement.
Device Description
Implant 3D is a software that allows to perform three-dimensional implant simulation directly on the PC. It enables to simulate the position of the implants in bi-dimensional and three-dimensional models. It also consent to identify the mandibular canal and to draw overviews and sections of the bone mode. Implant 3D enables to view the three dimensional bone model with the possibility to provide a qualitative indication of bone density. Implant 3D generates the overview, the sections and the three-dimensional bone model by reading the axial images.
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