DS Core CBCT Anatomy
K-Number: K260785 · 2026-04-23
ApplicantDentsply Sirona
Decision Date2026-04-23
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DS Core CBCT Anatomy is a medical device manufactured by Dentsply Sirona. It received FDA 510(k) clearance on 2026-04-23 under approval number K260785. 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 CBCT Anatomy?
DS Core CBCT Anatomy is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Dentsply Sirona. The 510(k) number is K260785.
When was DS Core CBCT Anatomy approved by the FDA?
DS Core CBCT Anatomy received FDA 510(k) clearance on 2026-04-23, under approval number K260785.
What company makes DS Core CBCT Anatomy?
DS Core CBCT Anatomy is manufactured by Dentsply Sirona.
What is the FDA product code for DS Core CBCT Anatomy?
The FDA product code for DS Core CBCT Anatomy 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.