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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.
 
DeviceCALCIVIS Imaging System
Generic NameCaries detection product with drug or biologic
ApplicantCalcivis Limited
Nine Edinburgh Bioquarter 9 Little France Rd.
Edinburgh 
PMA NumberP170029
Supplement NumberS004
Date Received12/03/2024
Decision Date03/03/2025
Product Code QJX 
Advisory Committee Dental
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the manufacturing scale up of the drug product (photoprotein) for use in the CALCIVIS Imaging System
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