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510(k) Data Aggregation
K Number
K060267Device Name
VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE
Manufacturer
IMPLANT LOGIC SYSTEMS, LTD.
Date Cleared
2006-03-17
(44 days)
Product Code
LLZ, PIC
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
IMPLANT LOGIC SYSTEMS, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and pre-planning of dental implant surgery.
Device Description
Virtual Implant Placement, or simply VIP, is a software program that will allow dental implant clinicians to pre-plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will presents the clinician with various reformatted CT images of their patient's jaw(s), allow the placement and manipulation of virtual implants, and provide measurement and other tools to assist the clinician. In typical usage a dentist evaluating a patient for dental implant surgery will often refer the patient for a CT scan to better visualize the patient's anatomy, and check the amount and density of the bone for its suitability for placing implants. The CT scan site will return the axial images from the CT scan on a CD in industry-standard DICOM format. Upon receipt of the CD, the doctor will "process" the case using VIP. Axial images are well-known to radiologists, but foreign to dentists. Processing involves the removal of unnecessary images which are outside the region of interest, and drawing a curve which will be used for the later reformatting of the data to produce images more familiar to dentists. After opening a disk of images, VIP will display the axial images and thumbnails of these, along with a scout view and a checklist of stops to follow in processing the case. After the case has been processed, the axial data will be processed to make panoramic images, which are parallel to the curve that was drawn during processing, and cross-sectional images, which are perpendicular to the panoramic image. Both types of images are normally generated by the Panorex machines dentists are familiar with. Since the primary purpose of VIP is to aid in the planning of implant surgeries, VIP will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy. The simulated implants will be generic models of standard dental implants, which range from cylindrical to conical. When the data becomes available from various implant manufacturers, VIP will allow the user to pick from specific, currently-manufactured implants to approximately model any of their favorite implants.
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