ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Dentsply Intl., GC America, Inc. and Heraeus Kulzer, Inc..

402
Total
402
Cleared
95d
Avg days
1976
Since
402 devices
25–48 of 402
Cleared Nov 28, 2018
Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
K181604
Hrs Co., Ltd.
Dental · 162d
Cleared Sep 13, 2018
HySil Impression Materials
K181236
Osstem Implant Co., Ltd.
Dental · 126d
Cleared Jul 12, 2018
AIM2
K181011
GC America, Inc.
Dental · 86d
Cleared Jun 13, 2018
PEAK NS033CF, PEAK NS017CF
K180565
Neosil Co., Ltd.
Dental · 100d
Cleared Apr 13, 2018
Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
K171562
Dreve Dentamid GmbH
Dental · 318d
Cleared Jun 07, 2017
HySil Impression Materials
K170736
Osstem Implant Co., Ltd.
Dental · 89d
Cleared May 27, 2016
NoCord
K152826
Centrix, Inc.
Dental · 241d
Cleared Sep 21, 2015
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262
Osstem Implant Co., Ltd.
Dental · 131d
Cleared Apr 03, 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575
Ivoclar Vivadent, Inc.
Dental · 107d
Cleared May 10, 2012
GC BLUE SILICONE
K120521
GC America, Inc.
Dental · 79d
Cleared Feb 13, 2012
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
K113406
Dentsply International, Inc.
Dental · 87d
Cleared Jun 17, 2011
FIT CHECKER ADVANCED
K110871
GC America, Inc.
Dental · 80d
Cleared Mar 28, 2011
FIT TEST C&B
K110050
Voco GmbH
Dental · 80d
Cleared Jul 31, 2009
FLEXITIME FLOW
K091494
Heraeus Kulzer, Inc.
Dental · 72d
Cleared Apr 11, 2008
CEREC OPTI SPRAY
K080882
Sirona Dental Systems GmbH
Dental · 11d
Cleared Jul 17, 2006
VIRTUAL
K060891
Ivoclar Vivadent, Inc.
Dental · 108d
Cleared Jun 26, 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427
Dentsply Intl.
Dental · 34d
Cleared Jan 03, 2006
EXPASYL POWER APPLICATOR
K051933
Sybron Dental Specialties, Inc.
Dental · 174d
Cleared Jun 28, 2005
MODIFICATION TO:REGISTRADO X-TRA
K051535
Voco GmbH
Dental · 18d
Cleared Apr 15, 2005
KERR VPS IMPRESSION MATERIAL
K050604
Sybron Dental Specialties, Inc.
Dental · 37d
Cleared Mar 04, 2005
FUSION PUTTY TYPE
K043493
GC America, Inc.
Dental · 77d
Cleared Jan 27, 2005
FUSION FAST
K043471
GC America, Inc.
Dental · 42d
Cleared Dec 17, 2004
FLEXITIME XTREME
K042878
Heraeus Kulzer, Inc.
Dental · 60d
Cleared Jun 25, 2004
GC FUSION
K041398
GC America, Inc.
Dental · 30d