FDA Product Code EJK: Liner, Cavity, Calcium Hydroxide
Leading manufacturers include Dmp Dental Industry S.A. and 3M Espe Dental Products.
FDA 510(k) Cleared Liner, Cavity, Calcium Hydroxide Devices (Product Code EJK)
About Product Code EJK - Regulatory Context
510(k) Submission Activity
77 total 510(k) submissions under product code EJK since 1976, with 77 receiving FDA clearance (average review time: 92 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
Recent submissions under EJK have taken an average of 106 days to reach a decision - up from 92 days historically. Manufacturers should account for longer review timelines in current project planning.
EJK devices are reviewed by the Dental panel. Browse all Dental devices →