FDA.report

510(k) K253009

Device
DS Core Detect
Applicant
Dentsply Sirona, Inc.
510(k) number
K253009
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-07
Date received
2025-09-19
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Deepthi Paknikar
Address
221 W. Philadelphia St. York PA US 17401 17401

FDA Registration Numbers

Source Documents

510(k) summary PDF

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