Vendor
8 FDA submission entries in this directory. This is not a count of distinct commercial offers.
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Pearl, Inc.
Authorized purpose: Second Opinion Panoramic is an automated image-processing aid that identifies and marks regions of interest for caries, periapical radiolucency, and impacted third molars on panoramic radiographs of permanent teeth in patients aged 16 years and older.
Pearl Inc.
Authorized purpose: Acts as a CADe second reader to detect and segment caries on periapical radiographs of permanent teeth in patients aged 12 years and older; clinicians review the contours and percentage analysis in context.
Pearl, Inc.
Authorized purpose: Second Opinion 3D processes dental CBCT radiographs to identify and mark dentition, maxilla, mandible, inferior alveolar canal and mental foramen, maxillary sinus, nasal space, and airway for review by dental health professionals age 12 and older; it is a concurrent or second reader, not a sole diagnosis.
Pearl Inc.
Authorized purpose: Second Opinion BLE identifies and displays bone-level measurements in bitewing and periapical radiographs for dental health professionals reviewing permanent teeth in patients age 12 and older as a concurrent or second reader, not as a sole diagnosis.
Pearl, Inc.
Authorized purpose: Aids dental professionals in detecting caries on digital bitewing and periapical radiographs from patients aged 4 years and older with primary, permanent, or mixed dentition; polygon overlays require clinical review.
Pearl Inc.
Authorized purpose: Second Opinion PC assists dentists by detecting and displaying periapical radiolucencies with bounding polygons on dental radiographs of permanent teeth in patients age 12 and older as a concurrent or second reader, not a replacement for complete dental evaluation.
Pearl Inc.
Authorized purpose: Second Opinion CC assists dental health professionals as a second reader for caries on bitewing and periapical radiographs of permanent teeth in patients 19 years or older, displaying editable polygonal contours for clinician review; it does not replace a complete dentist review or clinical judgment.
Pearl Inc.
Authorized purpose: Second Opinion is a concurrent-reading aid for dental professionals reviewing bitewing and periapical radiographs of permanent teeth in patients aged 12 years and older.