Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Analyzer, Medical Image
510(k) Number K253009
Device Name DS Core Detect
Applicant
Dentsply Sirona, Inc.
221 W. Philadelphia St.
York,  PA  17401
Applicant Contact Deepthi Paknikar
Correspondent
Dentsply Sirona, Inc.
221 W. Philadelphia St.
York,  PA  17401
Correspondent Contact Deepthi Paknikar
Regulation Number892.2070
Classification Product Code
MYN  
Date Received09/19/2025
Decision Date 01/07/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-