ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Zhermack S.P.A., Dentsply Intl. and Cavex Holland BV.

402
Total
402
Cleared
95d
Avg days
1976
Since
402 devices
73–96 of 402
Cleared Jun 17, 2011
FIT CHECKER ADVANCED
K110871
GC America, Inc.
Dental · 80d
Cleared Apr 08, 2011
TAKE 1 ADVANCED RIGID TRAY
K110092
Kerr Corporation
Dental · 86d
Cleared Apr 05, 2011
IMPRESSION COMPOUND
K110378
Spofadental
Dental · 83d
Cleared Mar 30, 2011
IOS FASTSCAN SPRAY
K103586
Ios Technnologies, Inc.
Dental · 113d
Cleared Mar 28, 2011
FIT TEST C&B
K110050
Voco GmbH
Dental · 80d
Cleared Feb 11, 2011
DELIKIT PUTTY, DELIKIT HEAVY BODY, DELIKIT LIGHT BODY
K103346
Sherpa Korea
Dental · 88d
Cleared Nov 10, 2010
VONFLEX HEAVY, VINFLEX LIGHT
K103164
Vericom Co., Ltd.
Dental · 14d
Cleared Jan 28, 2010
TAKE 1 ADVANCED RIGID TRAY
K092176
Kerr Corporation
Dental · 191d
Cleared Jul 31, 2009
FLEXITIME FLOW
K091494
Heraeus Kulzer, Inc.
Dental · 72d
Cleared May 06, 2009
VONFLEX PUTTY
K091267
Vericom Co., Ltd.
Dental · 6d
Cleared Mar 26, 2009
HYDRORISE AND HYDROSYSTEM
K083739
Zhermack S.P.A.
Dental · 100d
Cleared May 14, 2008
COLORISE RIGID
K081084
Zhermack S.P.A.
Dental · 28d
Cleared Apr 11, 2008
CEREC OPTI SPRAY
K080882
Sirona Dental Systems GmbH
Dental · 11d
Cleared Mar 26, 2008
PECD-01 AND PECD QUICK-01
K080514
3M Espe AG Dental Products
Dental · 30d
Cleared Mar 14, 2008
OCCLUFAST CAD
K080130
Zhermack S.P.A.
Dental · 56d
Cleared Dec 12, 2007
ELITE GLASS
K073005
Zhermack S.P.A.
Dental · 49d
Cleared Nov 08, 2007
EMULATE ADVANCED
K072245
Cavex Holland BV
Dental · 87d
Cleared May 11, 2007
COLORISE
K070677
Zhermack S.P.A.
Dental · 60d
Cleared Apr 25, 2007
FREEALGIN
K070700
Zhermack S.P.A.
Dental · 43d
Cleared Nov 16, 2006
IMPRESSIX, COLORCHANGE ALGINATE
K062400
Cavex Holland BV
Dental · 92d
Cleared Jul 17, 2006
VIRTUAL
K060891
Ivoclar Vivadent, Inc.
Dental · 108d
Cleared Jul 10, 2006
SIMULATE, COLOR CHANGE ALGINATE
K061267
Cavex Holland BV
Dental · 66d
Cleared Jun 26, 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427
Dentsply Intl.
Dental · 34d
Cleared Mar 01, 2006
COLORBITE
K053619
Zhermack S.P.A.
Dental · 64d