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FDA-cleared K251002

Videa Dental AI

VideaHealth Inc.

Authorized purpose: Analyzes bitewing, periapical, and panoramic intraoral radiographs from patients aged 3 years and older to identify and localize specified suspected dental findings, historical treatments, and normal anatomy; diagnostic use remains with trained dental professionals.

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-19
FDA-cleared K232384

Videa Dental Assist

VideaHealth, Inc.

Authorized purpose: Identify and localize listed dental findings, historical treatments, and normal anatomy on bitewing, periapical, and panoramic intraoral radiographs for patients aged 3 years and older, with indication-specific age and view limits; suspect dental-finding indications are adjunctive and diagnostic use is limited to dentists.

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial (suspected findings, historical treatments, and normal anatomy)
Decision
2023-12-15
FDA-cleared K223296

Videa Perio Assist

VideaHealth, Inc.

Authorized purpose: Aids dental professionals in measuring and visualizing mesial and distal bone levels for each tooth on bitewing and periapical radiographs.

Modality
X-ray/Radiography
Anatomy
Teeth and mesial/distal alveolar bone levels
Decision
2023-02-06
FDA-cleared K213795

Videa Caries Assist

VideaHealth, Inc

Authorized purpose: Concurrent-read CADe to identify and localize carious lesions on bitewing radiographs from adults at least 22 years old for board-licensed dentists; the device is an aid and does not replace dentist diagnosis.

Modality
X-ray/Radiography
Anatomy
Teeth and tooth surfaces, including proximal, buccal/lingual, occlusal, root, and cervical surfaces
Decision
2022-04-21