EKO · Class II · 21 CFR 872.3600

FDA Product Code EKO: Denture Preformed (partially Prefabricated Denture)

Leading manufacturers include Flexodent Corp., Advanced Marketing Research Co. and Zinnanti Surgical Instruments, Inc..

4
Total
4
Cleared
44d
Avg days
1976
Since

FDA 510(k) Cleared Denture Preformed (partially Prefabricated Denture) Devices (Product Code EKO)

4 devices
1–4 of 4
Cleared Dec 05, 1990
DENE BRIDGE
K903672
Dirotian Pty. , Ltd.
Dental · 113d
Cleared May 01, 1989
DENTAL ROOT ELEVATOR
K892255
Zinnanti Surgical Instruments, Inc.
Dental · 27d
Cleared May 26, 1978
ADVANCED DENTURE SYSTEM
K780722
Advanced Marketing Research Co.
Dental · 25d
Cleared Oct 15, 1976
FLEXIDENT DENTURE
K760768
Flexodent Corp.
Dental · 11d

About Product Code EKO - Regulatory Context