FDA-cleared K260785

DS Core CBCT Anatomy

Dentsply Sirona

DS Core CBCT Anatomy uses CBCT and digital-impression data to provide tooth and jaw segmentation, inferior-alveolar-nerve-canal segmentation, panoramic-curve support, and...

Modality
CBCT
Anatomy
Teeth; jaws; and the inferior alveolar nerve canal
Decision
2026-04-23
FDA-cleared K252538

CEPHX3D

Orca Dental AI, Ltd.

CEPHX3D processes dental and craniomaxillofacial images to support diagnosis and treatment planning, including three-dimensional models, viewing, segmentation, measurements, and...

Modality
CBCT
Anatomy
Dental and craniomaxillofacial anatomy
Decision
2026-03-05
FDA-cleared K252934

Diagnocat

DGNCT, LLC

Diagnocat is an automated concurrent-read aid for detecting periapical radiolucency on permanent teeth in previously acquired, clinically justified maxillofacial CBCT; it is a...

Modality
CBCT
Anatomy
Maxillofacial region; permanent teeth; periapical radiolucency
Decision
2026-01-15
FDA-cleared K253009

DS Core Detect

Dentsply Sirona, Inc.

FDA product code MYN identifies this device class as Analyzer, Medical Image. For information on the MYN device, please see:...

Modality
CBCT
Anatomy
N/A
Decision
2026-01-07
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 K251072

Segmentron Viewer

DGNCT, LLC

Segmentron Viewer is an AI web application for processing and manipulating maxillofacial radiographic images, viewing and segmenting three-dimensional CBCT data, and creating...

Modality
CBCT
Anatomy
Maxillofacial anatomy and permanent dentition
Decision
2025-09-09
FDA-cleared K250755

DS Core Diagnosis

Dentsply Sirona Inc.

FDA product code QIH identifies this device class as Automated Radiological Image Processing Software. To provide automated radiological image processing and analysis tools....

Modality
CBCT
Anatomy
N/A
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 K240465

O-arm O2 Imaging System

Medtronic Navigation, Inc

O-arm O2 4.3.0 provides mobile intraoperative two- and three-dimensional X-ray imaging of bony anatomy and metal objects, navigation support, 3D Long Scan, implant artifact...

Modality
CBCT
Anatomy
Spine
Decision
2024-06-21
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
FDA-cleared K232698

NemoScan

Software Nemotec S.L.

NemoScan supports dental CT or cone-beam CT visualization, segmentation, implant and surgical planning, instrument positioning, and guide planning from preoperative maxillofacial...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2024-01-18
FDA-cleared K231757

Ez3D-i /E3

Ewoosoft Co., Ltd

Ez3D-i/E3 provides dental and maxillofacial DICOM viewing, three-dimensional visualization, multiplanar reconstruction, two-dimensional analysis, implant simulation, canal...

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2023-07-14
FDA-cleared K192571

NemoScan

Software Nemotec S.L.

NemoScan supports dental implantology by segmenting and transferring anatomy from CT or cone-beam CT images for implant and surgical planning.

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2019-12-11