EKR · Class I · 21 CFR 872.4565

FDA Product Code EKR: Plugger, Root Canal, Endodontic

Leading manufacturers include Young O/S, LLC, B&L Biotech Co., Ltd. and Dentsply Intl..

6
Total
6
Cleared
109d
Avg days
1979
Since

FDA 510(k) Cleared Plugger, Root Canal, Endodontic Devices (Product Code EKR)

6 devices
1–6 of 6
Cleared Jun 05, 2006
B&L L-BETA, MODEL WL-B1
K060347
B&L Biotech Co., Ltd.
Dental · 115d
Cleared Dec 01, 2004
OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700
K042828
Young O/S, LLC
Dental · 50d
Cleared Mar 26, 1986
ENDODONTIC ROOT CANAL PLUGGER
K860569
Dentsply Intl.
Dental · 43d

About Product Code EKR - Regulatory Context