EKM · Class I · 21 CFR 872.3850

FDA Product Code EKM: Gutta-percha

Leading manufacturers include Unitek Corp., Pulpdent Corp. and Tulsa Dental Products, Ltd..

23
Total
23
Cleared
87d
Avg days
1982
Since

FDA 510(k) Cleared Gutta-percha Devices (Product Code EKM)

23 devices
1–23 of 23
Cleared Jul 21, 1997
ANTIBACTERIAL GUTTA PERCHA
K971641
Dr. Howard Martin, P.A.
Dental · 80d
Cleared Mar 21, 1997
THERMAPREP PLUS OVEN
K970134
Tulsa Dental Products, Ltd.
Dental · 65d
Cleared Feb 14, 1990
ENDO-PREP
K896663
Pulpdent Corp.
Dental · 82d
Cleared Sep 26, 1983
HEATED GUTTA PERCHA DELIVERY SYSTEM
K832654
Unitek Corp.
Dental · 49d

About Product Code EKM - Regulatory Context