FDA-cleared K252953

Velmeni for Dentists (V4D) Endo-Perio

Velmeni, Inc.

Concurrent-read CADe to assist dentists in detecting specified tooth and jaw anatomy, bone-level landmarks, and root-canal-treated teeth in digital radiographs of permanent teeth...

Modality
X-ray/Radiography
Anatomy
Permanent teeth and jaw/maxillofacial anatomy, including enamel, dentine, pulp, root, mental foramen, inferior alveolar canal, maxillary sinus, cementoenamel junction, crestal bone, and root-canal-treated teeth
Decision
2026-05-11
FDA-cleared K250753

VELMENI for DENTISTS (V4D)

Velmeni Inc.

Assists dentists in detecting caries, fillings/restorations, fixed prostheses, and implants on digital bitewing, periapical, and panoramic radiographs of permanent teeth in...

Modality
X-ray/Radiography
Anatomy
Dental/Maxillofacial
Decision
2025-09-02
FDA-cleared K240003

Velmeni for Dentists (V4D)

Velmeni Inc.

VELMENI for DENTISTS is concurrent-read, computer-assisted detection software intended to assist dentists in the clinical detection of dental caries, fillings or restorations,...

Modality
X-ray/Radiography
Anatomy
Permanent teeth; digital bitewing, periapical, and panoramic dental radiographs
Decision
2024-08-30