EBG · Class II · 21 CFR 872.3770

FDA Product Code EBG: Crown And Bridge, Temporary, Resin

Leading manufacturers include GC America, Inc., Ivoclar Vivadent, Inc. and Sybron Dental Specialties, Inc..

189
Total
189
Cleared
118d
Avg days
1977
Since
189 devices
49–72 of 189
Cleared Jan 19, 2016
DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
K152215
Dentalplus GmbH
Dental · 165d
Cleared Nov 23, 2015
YAMAHACHI PMMA DISKS
K151764
Yamahachi Dental Products USA, Inc.
Dental · 146d
Cleared Sep 14, 2015
SuPro 100
K151144
3M Deutschland GmbH
Dental · 138d
Cleared Aug 14, 2015
IDODENTINE DISC, IDODENTINE BLOCK
K150432
Union Dental S.A.
Dental · 176d
Cleared Apr 24, 2015
Luminesse PMMA
K142371
Talladium, Inc.
Dental · 242d
Cleared Feb 12, 2015
TIZIAN BLANK, TIZIAN ZIRCONIUM REINFORCED COMPOSITE BLANK, TIZIAN COLOR BLANK, TIZIAN BLANK OCCLUSAL, TIZIAN BLANK TRANS
K133268
Schutz-Dental GmbH
Dental · 476d
Cleared Feb 09, 2015
PMMA BLOCK
K141421
Rizhao Huge Dental Industry Co., Ltd.
Dental · 255d
Cleared Sep 05, 2014
MSN-006
K141562
GC America, Inc.
Dental · 85d
Cleared Jul 31, 2014
ARGEN PMMA
K140894
The Argen Corporation
Dental · 114d
Cleared May 21, 2014
HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)
K132937
Harvest Dental Products, LLC
Dental · 245d
Cleared Dec 18, 2013
COPRA TEMP PMMA-DISK
K131664
White Peaks Dental Systems GmbH & Co. KG
Dental · 194d
Cleared Feb 21, 2013
PEKKTON IVORY
K123638
Cendres & Metaux SA
Dental · 87d
Cleared Dec 27, 2012
KINGSCROSS PL-C+B-10, KINGSCROSS PL-C+B-12, KINGSCROSS PL-C+B-08, KINGSCROSS B
K122039
Kettenbach GmbH & Co. KG
Dental · 169d
Cleared Oct 09, 2012
BRIGHTGLASS BRIGHTGLASS M
K122025
Ktk Medical Supplies GmbH
Dental · 90d
Cleared Aug 28, 2012
PMMA CAD/CAM DISC
K112967
Polident D.O.O., Dental Products Industry
Dental · 328d
Cleared Jun 08, 2012
TUFF-TEMP 2.0
K120784
Pulpdent Corporation
Dental · 85d
Cleared Jun 01, 2012
STRUCTUR 3
K120779
Voco GmbH
Dental · 79d
Cleared Nov 08, 2011
FIBER DISK AND BLOCK
K112186
Bioloren S.R.L.
Dental · 102d
Cleared Sep 07, 2011
EVADYNE TEMPORARY CROWN AND BRIDGE RESIN
K111666
Neodental Chemical Products Co., Ltd.
Dental · 85d
Cleared Jun 14, 2011
TEMPFLEX
K110747
Kerr Corporation
Dental · 89d
Cleared May 25, 2011
PRO-V COAT
K103514
Bisco, Inc.
Dental · 176d
Cleared May 17, 2011
SELF CURE TEMPORARY CROWN AND BRIDGE MATERIAL
K110484
Novocol, Inc.
Dental · 88d
Cleared Feb 14, 2011
TELIO CS INLAY & TELIO CS ONLAY
K103379
Ivoclar Vivadent, Inc.
Dental · 89d
Cleared Feb 07, 2011
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
K103474
Micerium S.P.A.
Dental · 73d