ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Dentsply Intl., 3M Company and Osstem Implant Co., Ltd..

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 26, 2006
PRE-IMPRESSION CONDITIONING SOLUTION
K061427
Dentsply Intl.
Dental · 34d
Cleared May 13, 2002
AQUASIL ULTRA MONOPHASE/HEAVY/LV SMART WETTING IMPRESSION MATERIAL
K021416
Dentsply Intl.
Dental · 10d
Cleared May 10, 2002
AQUASIL ULTRA RIGID SMART WETTING IMPRESSION MATERIAL
K021413
Dentsply Intl.
Dental · 7d
Cleared May 08, 2002
AQUASIL ULTRA XLV SMART WETTING IMPRESSION MATERIAL
K021410
Dentsply Intl.
Dental · 5d
Cleared Jun 11, 1998
3M M.G. MATERIAL
K981325
3M Company
Dental · 59d
Cleared Dec 11, 1997
AQUASIL EASY MIX PUTTY IMPRESSION MATERIAL
K973781
Dentsply Intl.
Dental · 69d
Cleared Dec 04, 1997
AQUASIL XLV SMART WETTING IMPRESSION MATERIAL
K973782
Dentsply Intl.
Dental · 62d
Cleared Mar 27, 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433
Dentsply Intl.
Dental · 50d
Cleared Oct 31, 1996
3M PROPLUS SYSTEM
K963766
3M Company
Dental · 42d
Cleared Aug 13, 1996
JELTRATE PLUS ANTIMICROBIAL IMPR. MATERIAL
K952614
Dentsply Intl.
Dental · 435d
Cleared Aug 23, 1994
CAPTURE IMPRESSION MATERIAL
K943574
Dentsply Intl.
Dental · 32d
Cleared Apr 28, 1994
PRETREATMENT SOLUTION
K940685
Dentsply Intl.
Dental · 77d
Cleared Aug 09, 1993
FAST SET VINYLPOLYSILOXANE BITE REG. MATERIAL
K932459
3M Company
Dental · 80d
Cleared Apr 17, 1989
DICOR CERAMIC INLAY - NEW TECHNIC
K884166
Dentsply Intl.
Dental · 195d
Cleared Mar 17, 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842
Dentsply Intl.
Dental · 186d
Cleared Aug 11, 1988
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690
3M Company
Dental · 42d
Cleared Dec 01, 1986
HYDROPHILIC REPROSIL
K863288
Dentsply Intl.
Dental · 98d
Cleared Sep 25, 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879
Dentsply Intl.
Dental · 57d
Cleared Mar 17, 1986
POLYJEL N.F. (NEW FORMULA)
K860146
Dentsply Intl.
Dental · 61d