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510(k) Data Aggregation
K Number
K213302Device Name
exoplan
Manufacturer
exocad GmbH
Date Cleared
2022-05-03
(211 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
exocad GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
exoplan is a medical software, intended to support the planing of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal. exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representing the preoperative situation and approved implant positions. Alternatively, instead of optical surface data a second CBCT/CT dataset can be used. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product.
exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
Device Description
exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.
The software application runs on "off-the-shelf" PC hardware with Microsoft Windows 10 operating system (64 Bit), off-the shell GPU card and otherwise standard peripheral components.
The device allows importing 3D CT and optical scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the optical scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.
exoplan uses so called component libraries, which contain (e.g., physical dimensions, compatibility, etc.) provided by the original manufacturer of a component, and cover all components that can be used during treatment and necessary to consider during planning, e.g. implants, drills and drill sleeves. The libraries are digitally signed. This ensures that any modification of the content of a library will be detected by exoplan. The issue is then reported to the user and documented in the Implant Planning Report or the Surgical Protocol.
exoplan has no contact with the patient.
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K Number
K193352Device Name
AbutmentCAD
Manufacturer
exocad GmbH
Date Cleared
2021-07-21
(595 days)
Product Code
PNP, ABU
Regulation Number
872.3630Why did this record match?
Applicant Name (Manufacturer) :
exocad GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AbutmentCAD module is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Device Description
AbutmentCAD is a software application for the purpose of designing patient-specific implant-based dental restorations, such as one-piece abutments, two-piece/hybrid abutments and single or multi-unit screw retained restorations. The AbutmentCAD software can be used with basic dental CAD systems such as exocad's ChairsideCAD. AbutmentCAD is used solely for the patient-specific components of abutments and screw retained crowns and bridges. The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components.
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K Number
K183458Device Name
exoplan 2.3
Manufacturer
exocad GmbH
Date Cleared
2019-08-06
(236 days)
Product Code
LLZ
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
exocad GmbH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
exoplan is a medical software, intended to support the planning of dental implants using the visualization of the implant placement within images of the patient's anatomy. The process is based on CT/CBCT data sets originating from other medical devices, and can be supported by optical scan(s) of the patient's anatomy as well as a virtual prosthetic proposal.
exoplan allows the design of surgical guides to support the placement of endosseous dental implants in guided surgery. The design of surgical guides is based on 3D surface data representive situation and approved implant positions. The software exports the planning and design results as geometrical data and a digital 3D model of the surgical guide to support the manufacture of a separate physical product. exoplan does not extend or change indications of dental implants. Usage of a surgical guide designed with the software does not change the necessary due diligence required compared to conventional (non-guided) surgery.
The software is intended to be used only by dental professionals with sufficient medical training in dental implantology and surgical dentistry in office environments suitable for reading diagnostic dental DICOM data sets. exoplan shall not be used for any purpose other than planning dental implant placement or design of surgical guides.
Device Description
exoplan is a standalone software application for the purpose of pre-operative implant planning and design of surgical guides to support the surgical intervention.
The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system (7, 8.1,10, 64 Bit), off-the shell GPU card and otherwise standard peripheral components.
The device allows importing 3D CT data and dental scan data (e.g. scans from teeth, dental impression, or stone models) from compatible intraoral or desktop scanners. While the planning of implant position is mainly based on the information of the CT data, the design of a surgical quide is based on the STL data of the dental scan. Both modalities are registered to a common coordinate system to ensure that the implant positions defined by a user can be used for design of a surgical guide.
exoplan uses so called Implant Libraries that contain information provided by the original manufacturer of a respective physical implant, reconstruction parts on top of the implant, such as stock abutments or titanium bases. Libraries also contain drilling sleeves and tools of surgical kit items, such as drills and drill handles. The libraries are digitally signed and by that any modification of a library content or the referred library parts of files will be detected by exoplan reported to the user and documented in an Implant Planning Report or Surgical Protocol document.
exoplan has no contact with the patient.
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