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Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments; implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.

Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals in detecting dental structures and producing dental charting data based on interpretation of 2D dental radiographs. The device is intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.

Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment. The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.

Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment. OCA-Ped is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Laver and results are pushed to the dashboard, which are in the Presentation Layer.

Overiet Charting Assist is a Medical Image Management and Processing System (MIMPS) intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overiet Charting Assist detects these finding (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinical judgment that considers other relevant information from the image or patient history.

Overjet Charting Assist is a Medical Image Management and Processing System (MIMPS) device aimed to assist dental professionals in detecting dental structures and producing dental charting data based on interpretation of 2D dental radiographs. The device is intended to detect natural dental structures including detection of tooth anatomy (enamel, pulp), and tooth numbering, as well as dental structures added through past restorative treatments: implants, crowns, endodontic treatment (previous root canal treatment), fillings. The device is intended to assist dental professionals in producing dental charts based on image analysis. The Overjet Charting Assist detects these findings on bitewing (BW) and periapical (PA) images for patients with primary and/or permanent teeth (Ages 5 and above), and panoramic (Pano) radiographs for patients with only permanent teeth. The device is not intended as a replacement for a complete clinician's review or clinical judgment that considers other relevant information from the image or patient history.

Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists. The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.

Overjet Periapical Radiolucency "PARL" Assist is a module within the Overjet Platform. The Overjet PARL Assist (OPA) software automatically detects periapical radiolucency on periapical radiographs. It is intended to aid dentists in the detection of periapical radiolucency. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by professionally trained and licensed dentists. Overjet PARL Assist is a software-only device which operates in three layers: a Network Layer, aPresentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.

Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.

Overjet Caries Assist (OCA) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment. OCA is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer. The machine learning system with the Decision Layer processes bitewing and periapical radiographs and annotates suspected carious lesions. It is comprised of four modules: - Image Preprocessor Module - Tooth Number Assignment Module - Caries Module - Post Processing

The Overjet Caries Assist (OCA) is a radiological, automated, concurrent read, computer-assisted detection software intended to aid in the detection and segmentation of caries on bitewing radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or that takes into account other relevant information from the image, patient history, and actual in vivo clinical assessment.

Overjet Caries Assist (OCA) is a radiological automated concurrent read computer-assisted detection (CAD) software intended to aid in the detection and segmentation of caries on bitewing radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete clinician's review or their clinical judgment that takes into account other relevant information from the image or patient history. OCA is a software-only device which operates in three layers - a Network Layer, a Presentation Layer, and a Decision Layer (as shown in the data flow diagram below). Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer. The Machine Learning System within the Decision Layer processes bitewing radiographs and annotates suspected carious lesions. It is comprised of four modules: - Image Classifier The model evaluates the incoming radiograph and predicts the ● image type between Bitewing and Periapical Radiograph. This classification is used to support the data flow of the incoming radiograph. As part of the classification of the image type any non-radiographs are classified as "junk" and not processed. These include patient charting information, or other non-bitewing or periapical radiographs. OCA shares classifier and Tooth Number modules with the Overjet Dental Assist product cleared under K210187. - . Tooth Number Assignment module - This module analyzes the processed image and determines what tooth numbers are present and provides a pixel wise segmentation mask for each tooth number. - Caries module - This module outputs a pixel wise segmentation mask of all carious lesions using an ensemble of 3 U-Net based models. The shape and location of every carious lesion is contained in this mask as the carious lesions' predictions. - Post Processing The overlap of tooth masks from the Tooth Number . Assignment Module and carious lesions from the Caries Module is used to assign specific carious lesions to a specific tooth. The Image Post Processor module annotates the original radiograph with the carious lesions' predictions.

Overjet Dental Assist is a radiological semi-automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, dentists and dental hygienists.

Overjet Dental Assist developed by Overjet Inc, is a radiological semi automated image processing software device intended to aid dental professionals in the measurements of mesial and distal bone levels associated with each tooth from bitewing and periapical radiographs. Overjet Dental Assist is a cloud native Software as a Medical Device that allows users to automate the measurement of interproximal bone levels for bitewing and periapical radiographs, review associated radiographs, view annotations, modify annotations.