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510(k) Data Aggregation
K Number
K230012Device Name
Atomica Planner
Manufacturer
Date Cleared
2023-02-02
(30 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
Atomica Technology, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
"Atomica Planner" is stand-alone software indicated for use by highly qualified dental professionals in the preoperative simulation-based planning of implant placements, and designing patients' 3D model surgical guides to support dental treatment surgeries (such as teeth replacement for Adult patients with missing/damaged teeth: taking into account dental functional & esthetic aspects).
" Atomica Planner" image-processing functions & tools provide users with 2D/3D visualization & segmentation for imported medical digital imaging (DICOM) datasets (acquired originally by optical/medical scanners, such as CT) to enhance the image-guided detection of suitable implant placements based on the evaluation of intraoral surrounding tissue. System users can also export patient plan dataset output with final surgical instructions PDF report, and the designed surgical guide 3D models in the imaging (STL) file format which is compatible with a wide range of 3rd parties manufacturing systems.
"Atomica Planner" system is intended to be used only by highly-qualified dental professionals with sufficient training in implantology & surgical dentistry as well as practical experience with using digital imaging technologies and in an environment suitable for reading diagnostic dental DICOM data sets.
Device Description
"Atomica Planner" is a standalone desktop application intended for pre-operative simulation-based planning of implant placements & dental surgical treatment (such as teeth replacement with missing/damaged teeth; taking into account dental functional & esthetic aspects). The system is intended to be used only by well-trained and highly qualified dental professionals, based mainly on medical digital image processing functions & tools (2D/3D visualization & segmentation). A project file is created from the patient's imported medical imaging (DICOM) dataset (generated originally by medical/optical scanners, such as CT) to support dental professionals in the implant placements detection and suitable sleeves/drills types selection according to the image-guided anatomical measurements/evaluations of (surrounding/adjacent roots & nerves, available bone mass/density, and variations in maxilla & mandible). System users can export their plan dataset outputs with final surgical instructions PDF report, and the designed surgical guide 3D models in the imaging (STL) file format which is compatible with a wide range of manufacturing systems. The software is designed to run on standard "PC" platforms that meet the identified minimum (SW/HW) requirements and the environment of use of the device is the "Professional Healthcare Facility". Results produced by " Atomica Planner's visualization-based diagnosis & planning tools for dental implant treatments are mainly dependent on the interpretation of qualified & well-trained dental professionals. "Atomica Planner" is a stand-alone software medical device and does not contact the human body, nor does it directly control or integrate with any physical or digital life-sustaining medical devices.
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