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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLogicon Caries Detection Software
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantCarestream Dental, LLC
1765 The Exchange
Atlanta, GA 30339
PMA NumberP980025
Supplement NumberS004
Date Received08/09/2019
Decision Date09/05/2019
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site in Atlanta, GA, USA for Logicon Caries Detection Software.
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