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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
DeviceCALCIVIS Imaging System
Generic NameCaries detection product with drug or biologic
ApplicantCalcivis Limited
Nine Edinburgh Bioquarter 9 Little France Road
PMA NumberP170029
Date Received09/26/2017
Decision Date03/07/2023
Product Code QJX 
Docket Number 23M-0863
Notice Date 03/10/2023
Advisory Committee Dental
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for The CALCIVIS Imaging System. The device is intended to be used by dental healthcare professionals on patients (6 years and older) with, or at risk of developing, demineralization associated with caries lesions, on accessible coronal tooth surfaces.The CALCIVIS Imaging System is indicated for use to provide images of active demineralization on tooth surfaces, as an aid to the assessment, diagnosis and treatment planning of demineralization associated with caries lesions.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
Supplements:  S001 S002 S003