FDA Product Code ELE: Implant, Subperiosteal
Leading manufacturers include KLS-Martin L.P..
4
Total
4
Cleared
161d
Avg days
1980
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Implant, Subperiosteal Devices (Product Code ELE)
4 devices
About Product Code ELE - Regulatory Context
510(k) Submission Activity
4 total 510(k) submissions under product code ELE since 1980, with 4 receiving FDA clearance (average review time: 161 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
ELE devices are reviewed by the Dental panel. Browse all Dental devices →