FDA-cleared K253930

Overjet Iris Intelligent Imaging System

Overjet, Inc.

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.

Modality
X-ray/Radiography
Anatomy
Teeth and maxillofacial anatomy
Decision
2026-04-10
FDA-cleared K251514

Overjet CBCT Assist

Overjet, Inc.

Dental and craniomaxillofacial CBCT segmentation, measurement and visualization support

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2025-12-05
FDA-cleared K241681

Overjet Image Enhancement Assist

Overjet Inc

Overjet Image Enhancement Assist provides optional image-quality enhancement for dental radiographs. The FDA material describes learning-based noise reduction for bitewing and...

Modality
X-ray/Radiography
Anatomy
Teeth and maxillofacial structures
Decision
2024-09-09
FDA-cleared K241684

Overjet Charting Assist

Overjet, Inc

Dental radiograph charting assistance for detecting natural and restorative dental structures and tooth numbering on bitewing, periapical, and panoramic images.

Modality
X-ray/Radiography
Anatomy
Dental/maxillofacial
Decision
2024-08-27
FDA-cleared K233738

Overjet Caries Assist-Pediatric

Overjet, Inc

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...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (carious tooth surfaces)
Decision
2024-03-04
FDA-cleared K233590

Overjet Charting Assist

Overjet, Inc

Assist dental professionals in producing dental charts by detecting tooth anatomy and numbering plus past restorative treatments on bitewing and periapical images for patients...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (tooth anatomy, numbering, and restorative structures)
Decision
2024-02-23
FDA-cleared K231678

Overjet Periapical Radiolucency Assist

Overjet, Inc

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...

Modality
X-ray/Radiography
Anatomy
Permanent teeth; periapical regions
Decision
2023-09-21
FDA-cleared K222746

Overjet Caries Assist

Overjet, Inc.

Concurrent-read CADe to aid professionally trained and licensed dentists in detecting and segmenting caries on bitewing and periapical radiographs; the output is additional...

Modality
X-ray/Radiography
Anatomy
Permanent dentition and tooth surfaces in dental/maxillofacial anatomy
Decision
2023-03-27
FDA-cleared K220928

Overjet Calculus Assist

Overjet Inc.

Concurrent-read CADe to aid professionally trained and licensed dentists in detecting interproximal calculus deposits on bitewing and periapical radiographs; the output is...

Modality
X-ray/Radiography
Anatomy
Interproximal tooth surfaces in dental/maxillofacial anatomy
Decision
2022-12-16
FDA-cleared K212519

Overjet Caries Assist

Overjet, Inc.

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...

Modality
X-ray/Radiography
Anatomy
Permanent dentition; tooth surfaces and caries
Decision
2022-05-10
FDA-cleared K210187

Overjet Dental Assist

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...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2021-05-19