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
49–72 of 402
Cleared Aug 15, 2014
VONFLEX S BITE
K140966
Vericom Co., Ltd.
Dental · 122d
Cleared Jun 19, 2014
SILDENT
K132869
Hrs Co., Ltd.
Dental · 279d
Cleared Jun 05, 2014
FLASH PENTA MB QUICK, FLASH MB QUICK
K140602
3M Espe AG
Dental · 87d
Cleared May 28, 2014
ELASTIC IMPRESSION MATERIAL
K133071
Rizhao Huge Dental Industry Co., Ltd.
Dental · 240d
Cleared May 21, 2014
HYGEDENT ALGINATE IMPRESSION MATERIAL
K140074
Hygedent, Inc.
Dental · 128d
Cleared Apr 09, 2014
MD-FLEX HEAVY BODY
K134008
Meta Biomed, Inc.
Dental · 100d
Cleared Mar 07, 2014
FLASH AR
K133436
3M Deutschland GmbH
Dental · 119d
Cleared Mar 07, 2014
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT
K133527
Osstem Germany GmbH
Dental · 112d
Cleared Mar 06, 2014
FLASH BITE
K133400
3M Espe AG
Dental · 120d
Cleared Feb 25, 2014
SMILEBOND SYSTEM
K132599
Millennium Company, LLC
Dental · 189d
Cleared Dec 20, 2013
POLYDIMETHYLSILOXANE IMPRESSION MATERIAL
K131510
Blackwell Device Consulting
Dental · 210d
Cleared Jul 02, 2013
CORRECT PLUS 1
K130920
Pentron Clinical
Dental · 90d
Cleared May 30, 2013
TAKE 1 ADVANCE
K130869
Sybron Dental Specialties
Dental · 62d
Cleared May 30, 2013
FLASH AR PENTA / FLASH AR PENTA QUICK
K131404
3M Deutschland GmbH
Dental · 15d
Cleared May 17, 2013
XANTASIL DYNAMIX FAST SET CARTRIDGE -2 X 380ML
K130647
Heraeus Kulzer, LLC
Dental · 67d
Cleared Aug 23, 2012
ALGINOR ALGINELLE TYPE 1 AND 2 MILLENIUM KROMOPAN 1 AND 2
K121824
Lascod Spa
Dental · 63d
Cleared Jul 25, 2012
FLEXITIME FAST & SCAN LIGHT FLOW
K120914
Heraeus Kulzer, LLC
Dental · 120d
Cleared Jul 13, 2012
FLEXITIME MONOPHASE PRO SCAN
K113574
Heraeus Kulzer, LLC
Dental · 224d
Cleared May 22, 2012
TEMPSPAN CLEAR MATRIX
K120013
Pentron Clinical
Dental · 140d
Cleared May 10, 2012
GC BLUE SILICONE
K120521
GC America, Inc.
Dental · 79d
Cleared May 02, 2012
FLASH (DIFFERENT MATERIALS)
K120438
3M Deutschland GmbH
Dental · 79d
Cleared Feb 13, 2012
AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL
K113406
Dentsply International, Inc.
Dental · 87d
Cleared Nov 14, 2011
ARGES IMAGING CONTRAST SPRAY
K113263
Arges Imaging, Inc.
Dental · 10d
Cleared Nov 14, 2011
IDENTIUM HEAVY, IDENTIUM MEDIUM, IDENTIUM SCAN HEAVY, IDENTIUM SCAN MEDIUM, IDENTIUM SCAN LIGHT
K113279
Kettenbach GmbH & Co. KG
Dental · 7d