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510(k) Data Aggregation
K Number
K210241Device Name
ImplaStation
Manufacturer
Date Cleared
2021-12-03
(308 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Prodigident, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
ImplaStation is stand-alone software designed for trained qualified dental practitioners, including dental technicians.
The software can be used to visualize a patient's medical image dataset output in DICOM format from third-party CT/ CBCT scanners.
ImplaStation is intended for use as a pre-operative tool for the dental implant(s) positioning based on the CT/CBCT image dataset aligned to optical 3D surface scan(s) and for the surgical guide planning result file creation. The surgical guide can be manufactured using a planning result file when used as input to 3D manufacturing systems.
3D manufacturing is out of ImplaStation software control, depends on many external factors and lie within the sole responsibility of the user.
Device Description
ImplaStation is stand-alone software designed for trained qualified dental practitioners.
The key scientific concept (807.92(a)(4)) of the ImplaStation software is the visualization of a patient's medical image data (DICOM file from third-party CT/CBCT scanners) to pre-operative digital implant planning, surgical guide (drill guide) file (output of the pre-operative implant planning) creation.
The data acquired by the optical scanner (scanned surface of the maxilla or mandible) can be aligned to the CT/CBCT reconstruction through a point-based registration technique.
Virtual crown(s) design and nerve tracing can be used as additional tools to assist the specialist during an implant planning process.
The ImplaStation library contains implant, abutment, drill, and sleeve files, which are encrypted files and approved by the corresponding implant manufactures. The software allows designing the surgical guide (drill guide) file and exporting the generated file to a 3th party external system for manufacturing. The device has no patient contact, nor does it control any life-sustaining devices.
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