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510(k) Data Aggregation
K Number
K173083Device Name
IMPLANTER DENTAL PLANNING SOFTWARE
Manufacturer
Implanter LLC
Date Cleared
2018-12-03
(430 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Implanter LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMPLANTER DENTAL PLANNING SOFTWARE is a device that employs previously scanned DICOM CT images in a software tool which serves as an aid to visualizing and preplanning of dental implant surgery.
Device Description
The Implanter Dental Implant Planning Software is a software aimed to help simplifying dental implant surgery and enhancing its mechanical and esthetic implications in the prosthetic stage. Implanter Dental Implant Planning Software allows dental implant professionals to plan their implant surgeries and/or to design surgical appliances that will be used during surgery. The program will present the clinician with various reformatted CT/CBCT 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. Since the primary purpose of Implanter Dental Implant Planning Software is to aid the planning of implant surgeries, Implanter Dental Implant Planning Software will allow the surgeon to place simulated implants on the image and to gauge their size and position relative to the surrounding anatomy.
Implanter is a digital image processing software for Windows that loads images in DICOM format (CT and CBCT images) and rebuilds them in order to get different views that allows the dentist to assess the patient´s anatomy, plan a dental implant surgery, and design a printable surgical guide based on the former.
The software allows the dentist to:
- · use a dental virtual implant gallery to plan a surgery choosing the proper implant size. The IMPLANTER software contains a virtual dental implants library based on the Groovy Implants from Noble Biocare® (FDA cleared under K050258).
- Implanter Dental Planning Software generates 3D models and exports these . models in a format suitable for 3D printing to be used as physical models for visualization or educational purposes only. This clearance does not cover medical devices manufactured from those output files.
- save the surgical planning session of a patient for later analysis. .
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