FDA-cleared K250755

DS Core Diagnosis

Dentsply Sirona Inc.

Displays and supports interpretation of digital/digitized dental media, including CBCT and other 2D/3D X-ray images; its Panoramic Curve Proposal generates a proposed dental-arch...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2025-08-12
FDA-cleared K243989

Second OpinionĀ® 3D

Pearl, Inc.

Second Opinion 3D processes dental CBCT radiographs to identify and mark dentition, maxilla, mandible, inferior alveolar canal and mental foramen, maxillary sinus, nasal space,...

Modality
CBCT
Anatomy
Dental and craniomaxillofacial anatomy
Decision
2025-05-23
FDA-cleared K233925

Relu Creator

Relu BV

Relu Creator manages, transfers, displays, enhances, and analyzes dental and craniomaxillofacial image information and provides design input for dental solutions within the...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2024-06-13