FDA Product Code ELE: Implant, Subperiosteal
Leading manufacturers include KLS-Martin L.P., Katecho, Inc. and Jeneric Ind..
4
Total
4
Cleared
161d
Avg days
1980
Since
Stable submission activity - 0 submissions in the last 2 years
FDA 510(k) Cleared Implant, Subperiosteal Devices (Product Code ELE)
4 devices
Cleared
Jul 08, 2022
KLS Martin IPS Preprosthetic
KLS-Martin L.P.
Dental
526d
Cleared
Aug 29, 1986
SURGICAL VITEX
Jeneric Ind.
Dental
28d
Cleared
Nov 30, 1984
K-APATITE 20-40 MESH K-APATITE 40-60
Katecho, Inc.
Dental
81d
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 remained relatively stable over the observed period, with 0 submissions in the last 24 months.