Last synced on 25 January 2026 at 3:41 am

CALCIVIS Imaging System

Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Calcivis Limited
Trade Name
CALCIVIS Imaging System
Generic Name
Caries detection product with drug or biologic
Decision Date
3/7/2023
Days to Decision
1988 days
Decision Code
APPR
FDA Decision
Approval

CALCIVIS Imaging System

Page Type
PMA Approval
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
Calcivis Limited
Trade Name
CALCIVIS Imaging System
Generic Name
Caries detection product with drug or biologic
Decision Date
3/7/2023
Days to Decision
1988 days
Decision Code
APPR
FDA Decision
Approval