DS Core Detect— 510(k) K253009

Substantially Equivalent

Dentsply Sirona, Inc.

FDA 510(k) clearance K253009 for DS Core Detect, Substantially Equivalent on 2026-01-07. Applicant: Dentsply Sirona, Inc..

Clearance details

Applicant: Dentsply Sirona, Inc.
Product code: Code MYN
Advisory panel: Radiology
Date received: 2025-09-19
Decision date: 2026-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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