EKM · Class I · 21 CFR 872.3850

FDA Product Code EKM: Gutta-percha

Leading manufacturers include Tulsa Dental Products, Ltd., Endo Twinn B.V. and Dr. Howard Martin, P.A..

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 Feb 27, 2008
EI DOWNPAK BARRIER SLEEVES
K073369
Hu-Friedy Mfg. Co., Inc.
Dental · 89d
Cleared Feb 16, 2007
DOWN PAK
K070246
Endo Twinn B.V.
Dental · 22d
Cleared Jun 26, 2006
TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE)
K051573
Dr. Howard Martin, P.A.
Dental · 377d
Cleared Jan 11, 2005
ENDO TWINN
K042870
Endo Twinn B.V.
Dental · 85d
Cleared Mar 26, 2003
FIBERFILL SGP
K023819
Pentron Clinical Technologies
Dental · 131d
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 May 27, 1993
INJECT-R FILL
K931742
Union Broach, Div. Moyco Industries, Inc.
Dental · 50d
Cleared Mar 05, 1993
MICRODOSE RC-EZ
K924825
Unicep
Dental · 158d
Cleared Jan 21, 1992
TOUCH 'N HEAT MODEL 5002, MODIFICATION
K915243
Analytic Technology
Dental · 82d
Cleared Mar 29, 1991
THERMAPREP
K910224
Tulsa Dental Products, Ltd.
Dental · 70d
Cleared Nov 13, 1990
THERMAFIL ENDODONTIC OBTURATOR
K900986
Tulsa Dental Products, Ltd.
Dental · 257d
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