DS Core Diagnosis
K-Number: K250755 · 2025-08-12
ApplicantDentsply Sirona, Inc.
Decision Date2025-08-12
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DS Core Diagnosis is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2025-08-12 under approval number K250755. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DS Core Diagnosis?
DS Core Diagnosis is a medical device that received FDA 510(k) clearance on 2025-08-12. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K250755.
When was DS Core Diagnosis approved by the FDA?
DS Core Diagnosis received FDA 510(k) clearance on 2025-08-12, under approval number K250755.
What company makes DS Core Diagnosis?
DS Core Diagnosis is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for DS Core Diagnosis?
The FDA product code for DS Core Diagnosis is QIH.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.