DS Core Detect
K-Number: K253009 · 2026-01-07
ApplicantDentsply Sirona, Inc.
Decision Date2026-01-07
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DS Core Detect is a medical device manufactured by Dentsply Sirona, Inc.. It received FDA 510(k) clearance on 2026-01-07 under approval number K253009. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DS Core Detect?
DS Core Detect is a medical device that received FDA 510(k) clearance on 2026-01-07. It is manufactured by Dentsply Sirona, Inc.. The 510(k) number is K253009.
When was DS Core Detect approved by the FDA?
DS Core Detect received FDA 510(k) clearance on 2026-01-07, under approval number K253009.
What company makes DS Core Detect?
DS Core Detect is manufactured by Dentsply Sirona, Inc..
What is the FDA product code for DS Core Detect?
The FDA product code for DS Core Detect is MYN.
Other Devices by Dentsply Sirona, Inc.
Related Devices (Code: MYN)
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.