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11 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Overjet, Inc.
Authorized purpose: Overjet Iris is a web-based dental PACS for storing, viewing, and supporting image-quality review of two-dimensional intraoral radiographs, panoramic images, and color photographs.
Overjet, Inc.
Authorized purpose: Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support
Overjet Inc
Authorized purpose: Overjet Image Enhancement Assist provides optional image-quality enhancement for dental radiographs. The FDA material describes learning-based noise reduction for bitewing and periapical images and standard contrast and sharpness enhancement for bitewing, periapical, and panoramic images; source images are acquired and reviewed using standard dental imaging workflows.
Overjet, Inc
Authorized purpose: Dental radiograph charting assistance for detecting natural and restorative dental structures and tooth numbering on bitewing, periapical, and panoramic images.
Overjet, Inc
Authorized purpose: Aid dentists in detecting and segmenting caries on bitewing and periapical radiographs for patients aged 4-11 with primary or permanent teeth; the output is additional information and does not replace a complete dental review or clinical judgment.
Overjet, Inc
Authorized purpose: Assist dental professionals in producing dental charts by detecting tooth anatomy and numbering plus past restorative treatments on bitewing and periapical images for patients aged 5 and above with primary or permanent teeth, and on panoramic images for patients with only permanent teeth; not a replacement for clinician review.
Overjet, Inc
Authorized purpose: Overjet Periapical Radiolucency Assist is a concurrent-read aid for detecting periapical radiolucencies on periapical radiographs of permanent teeth in patients aged 12 years and older; it supplements, but does not replace, the dentist's review.
Overjet, Inc.
Authorized purpose: Concurrent-read CADe to aid professionally trained and licensed dentists in detecting and segmenting caries on bitewing and periapical radiographs; the output is additional information and does not replace dentist review or clinical judgment.
Overjet Inc.
Authorized purpose: Concurrent-read CADe to aid professionally trained and licensed dentists in detecting interproximal calculus deposits on bitewing and periapical radiographs; the output is additional information and does not replace full dentist review or judgment.
Overjet, Inc.
Authorized purpose: Overjet Caries Assist is a concurrent-read aid for detecting and segmenting caries on bitewing radiographs of permanent dentition in patients aged 18 years and older; it provides additional information for a dentist and is not a replacement for complete review or clinical judgment.
Overjet, Inc.
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. Intended Patient Population: The intended patient population of the device is patients living in the United States, who are 22 years old or older, and that do not have any remaining primary teeth. Overjet has not evaluated the performance of the device on primary dentition.