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
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 Oct 31, 2017
Rapid HB, Rapid LB, Rapid MB
K173318
3M Deutschland GmbH
Dental · 11d
Cleared Jul 26, 2017
HygePLUS Alginate Impression Material
K170812
Hygedent, Inc.
Dental · 131d
Cleared Jun 07, 2017
HySil Impression Materials
K170736
Osstem Implant Co., Ltd.
Dental · 89d
Cleared Nov 03, 2016
Vonflex S
K152615
Vericom Co., Ltd.
Dental · 416d
Cleared Sep 30, 2016
i-Sil
K161774
Spident Co., Ltd.
Dental · 94d
Cleared Aug 05, 2016
Image Fast Set, Image Regular Set
K160097
Sybron Dental Specialties
Dental · 199d
Cleared Jun 30, 2016
Identic and KromaFaze Alginate Dental Impression Materials
K160441
Kerr Corporation
Dental · 134d
Cleared May 27, 2016
NoCord
K152826
Centrix, Inc.
Dental · 241d
Cleared Mar 08, 2016
CharmFlex
K152766
Dentkist, Inc.
Dental · 166d
Cleared Mar 04, 2016
Aquasil Ultra + Smart Wetting Impression Material
K152861
Dentply International, Inc.
Dental · 156d
Cleared Nov 30, 2015
Vonflex S Putty
K152518
Vericom Co., Ltd.
Dental · 88d
Cleared Nov 23, 2015
Star+ VPS Scannable Impression Material
K152349
Danville Materials, LLC
Dental · 95d
Cleared Oct 28, 2015
Cavex Cream Alginate
K151535
Cavex Holland BV
Dental · 142d
Cleared Oct 22, 2015
PEAK
K152180
Neosil Co., Ltd.
Dental · 79d
Cleared Sep 21, 2015
Hyflex Heavy, Hyflex Mono, Hyflex Light
K151262
Osstem Implant Co., Ltd.
Dental · 131d
Cleared Jul 28, 2015
Elements
K151150
Pac-Dent International, Inc.
Dental · 89d
Cleared Apr 03, 2015
Accu-Dent XD Tray, Accu-Dent XD Syringe
K143575
Ivoclar Vivadent, Inc.
Dental · 107d
Cleared Feb 23, 2015
DentiAnn Smart Sil
K143382
Seilglobal Co., Ltd.
Dental · 90d
Cleared Dec 04, 2014
MARK3
K141092
Cavex Holland BV
Dental · 220d