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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 NumberS002
Date Received05/25/2023
Decision Date11/17/2023
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  
The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of the premarket approval application (PMA) 180-day supplement, which requested approval for modifications to the device components to include the lens design, fluid delivery mechanism, wireless communication, dock chiller chamber, and applicator redesign. The proposed modifications are to produce a smaller handheld imaging system with added wireless communication for the ease of use accessibility. The CDRH of the FDA has also completed its review of the PMA 180-day supplement for the site change of TT Electronics Dongguan, Dongguan City, China.
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