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510(k) Data Aggregation
K Number
K112251Device Name
SWISSMEDA DENTAL PLANNING SYSTEM
Manufacturer
SWISSMEDA AG
Date Cleared
2012-01-25
(173 days)
Product Code
LLZ, IVS
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SWISSMEDA AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Swissmeda Dental Planning System is intended for use by qualified dental professionals for Windows® based diagnostics and implant planning.
The software is an interface for imaging data that originates from medical scanners such as CT or DVT scanners and it is also a pre-operative software for simulation and evaluation of dental implant placement in the patient's mandible/maxilla and for surgical treatment options.
Swissmeda Implant Planning System is not intended to be used in direct contact with the patient nor is it intended to be used with life sustaining devices.
The planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning.
Device Description
Swissmeda Dental Planning System is a stand-alone software device.
It is a Windows® based software application for the visualization of imaging information of the patient's mandible/maxilla region. It is intended to be used for diagnostics and a precise and reproducible pre-operative planning of dental implants and surgical treatment by aid qualified dental professionals.
Imaging data from medical scanners such as CT or DVT scanners (DICOM Standard) will be read in. The software calculates a volumetric (3 dimensional) data set which will be displayed in different windows: One shows the data as volume data where every voxel of the data set is shown with a grey value that defines the density of the bone substance. Three other windows show a slice through the 3d data set as a flat image. During a planning session the data can be stored to pause the planning session and can be reloaded to continue the planning session.
By inspection of the 3d information of the bone the dental professional can deduct hints where to place what kind of implants. To support planning the user is enabled to predefine a dental occlusion spline and an occlusion plane. He can select implants from a given implant catalog and insert them into the 3d data set at the predefined position given by the dental spline and the tooth number. The implant catalog contains real geometry of several implants from several different vendors. Swissmeda Dental Planning System has no limitations regarding material or surface types of implants.
For each patient several versions of the plan can be created, restored and exported each time.
The final planning data may be exported from Swissmeda Dental Planning System and used as input data for a special drilling device from company Georg Schick Dental GmbH* for manufacturing drilling templates in a laboratory environment. The drilling template is then used in direct contact with the patient to realize the implant planning during the surgery.
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