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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 DETECTOR
Generic NameAnalyzer, medical image
Regulation Number892.2070
ApplicantCarestream Dental, LLC
1765 The Exchange
Atlanta, GA 30339
PMA NumberP980025
Supplement NumberS002
Date Received02/19/2013
Decision Date07/22/2014
Reclassified Date02/21/2020
Product Code MYN 
Advisory Committee Radiology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF SOFTWARE MODULE PRESCAN TO LOGICON CARIES DETECTOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME LOGICON CARIES DETECTOR AND HAS REVISED INDICATIONS FOR USE: THE LOGICON CARIES DETECTOR IS A SOFTWARE DEVICE THAT IS AN AID IN THE DIAGNOSIS OF CARIES THAT HAVE PENETRATED INTO THE DENTIN, ON UN-RESTORED PROXIMAL SURFACES OF SECONDARY DENTITION THROUGH THE STATISTICAL ANALYSIS OF DIGITAL INTRA-ORAL RADIOGRAPHIC IMAGERY. THE DEVICE PROVIDES ADDITIONAL INFORMATION FOR THE CLINICIAN TO USE IN HIS/HER DIAGNOSIS OF A TOOTH SURFACE SUSPECTED OF BEING CARIOUS. IT IS DESIGNED TO WORK IN CONJUNCTION WITH AN EXISTING CARESTREAM DENTAL RVG DIGITAL X-RAY RADIOGRAPHIC SYSTEM WITH DENTAL IMAGING SOFTWARE (DIS) FOR WINDOWS XP OR HIGHER.
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