EKG · Class I · 21 CFR 872.4565

FDA Product Code EKG: Condenser, Amalgam And Foil, Operative

Leading manufacturers include Miltex, Inc., Shofu Dental Corp. and Austenal Dental, Inc..

3
Total
3
Cleared
45d
Avg days
1982
Since

FDA 510(k) Cleared Condenser, Amalgam And Foil, Operative Devices (Product Code EKG)

3 devices
1–3 of 3
Cleared Feb 19, 1987
AUSTENAL CONDENSING INSTRUMENT
K865025
Austenal Dental, Inc.
Dental · 58d
Cleared Dec 03, 1984
ISOSTATIC CONDENSER
K843901
Shofu Dental Corp.
Dental · 61d
Cleared Nov 24, 1982
DENTAL INSTRUMENTS - PLUGGERS
K823322
Miltex, Inc.
Dental · 16d

About Product Code EKG - Regulatory Context