Premarket Approval (PMA)

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.

• Device: CALCIVIS Imaging System
• Generic Name: Caries detection product with drug or biologic
• Applicant: Calcivis Limited; Nine Edinburgh Bioquarter 9 Little France Road; Edinburgh
• PMA Number: P170029
• Supplement Number: S003
• Date Received: 09/12/2023
• Decision Date: 10/13/2023
• Product Code: QJX
• Docket Number: 24M-4267
• Notice Date: 09/17/2024
• Advisory Committee: Dental
• Supplement Type: Panel Track
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
Approval for the CALCIVIS Imaging System 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, monitoring and treatment planning of demineralization associated with caries lesions.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling