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FDA-cleared K253009

DS Core Detect

Dentsply Sirona, Inc.

Authorized purpose: Concurrent-read incidental detection of permanent teeth that may be associated with periapical radiolucencies in CBCT data acquired for other reasons.

Modality
CBCT
Anatomy
Permanent teeth and periapical dental structures
Decision
2026-01-07
FDA-cleared K250755

DS Core Diagnosis

Dentsply Sirona Inc.

Authorized purpose: 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 curve for patients aged 12 years and older with permanent dentition that a clinician can review and adjust.

Modality
CBCT
Anatomy
Dental/Maxillofacial
Decision
2025-08-12