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
169–192 of 402
Cleared Sep 02, 1998
ALGETRAL, CAVEX CHROMATIC, CA 37 SUPERIOR PINK, CA 37 FAST SET, CAVEX RAINBOW, CAVEX IMPRESSIONAL NORMAL SETTING, CAVEXI
K981970
Cavex Holland BV
Dental · 90d
Cleared Jun 11, 1998
3M M.G. MATERIAL
K981325
3M Company
Dental · 59d
Cleared Jun 09, 1998
LONE STAR IMPRESSION SYSTEMS
K980968
Lone Star Technologies
Dental · 85d
Cleared May 21, 1998
NEOCOLLOID, ORTHOPRINT
K981091
Zhermack S.P.A.
Dental · 57d
Cleared May 11, 1998
HONIGUM AUTOMIX IMPRESSION MATERIAL (FOIL BAGS) AND HONIGUM QUICK IMPRESSION MATERIAL (CARTRIDGES)
K980963
Foremost Dental Mfg., Inc.
Dental · 56d
Cleared May 01, 1998
SPECTRA FORM CHROMATIC ALGINATE IMPRESSION MATERIAL
K980965
Cavex Holland BV
Dental · 46d
Cleared Feb 12, 1998
KROMATICA COLOR CHANGING ALGINATE
K974894
Matech, Inc.
Dental · 43d
Cleared Jan 29, 1998
POSITION PENTA, POSITION PENTA QUICK
K974231
Espe GmbH & Co. Kg.
Dental · 78d
Cleared Jan 29, 1998
HYDROGUM
K974704
Zhermack S.P.A.
Dental · 44d
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 Nov 24, 1997
PROVIL NOVO
K973694
Heraeus Kulzer, Inc.
Dental · 59d
Cleared Oct 21, 1997
HYDROFLEX
K973343
GC America, Inc.
Dental · 46d
Cleared Oct 02, 1997
GENESIS
K972871
Pacific Rim Dental, Inc.
Dental · 59d
Cleared Aug 18, 1997
TULIP
K970129
Richard Ting
Dental · 215d
Cleared Aug 15, 1997
CEREC 2 CROWN SOFTWARE
K972276
Siemens AG
Dental · 58d
Cleared Aug 01, 1997
ELITE H-D VINYL POLYSILOXANE IMPRESSION MATERIALS .PUTTY SOFT/NORMAL SETTING /PUTTY SOFT/FAST SETTING
K972239
Zhermack S.P.A.
Dental · 46d
Cleared Jul 16, 1997
ELITE H-D HYDROPHILIC VINYL POLYSILOXANE IMPRESSION MATERIALS (LIGHT BODY/NORMAL,LIGHT BODY/FAST SETTING,REGULAR BODY,)
K972027
Zhermack S.P.A.
Dental · 44d
Cleared May 22, 1997
MEMOREG
K971155
Heraeus Kulzer, Inc.
Dental · 55d
Cleared Apr 08, 1997
HYDROFLEX
K970656
GC America, Inc.
Dental · 46d
Cleared Apr 04, 1997
SUPER-DENT ALGINATE,NORMAL SET, FAST SET,SUPER DELUXE DUSTLESS ALGINATE, NORMAL SET, DELUXE DUTLESS ALGINATE, FAST SET
K965083
S.S. White Mfg., Ltd.
Dental · 106d
Cleared Mar 31, 1997
KALGINATE IMPRESSION MATERIAL
K970594
Teledyne Water Pik
Dental · 41d
Cleared Mar 27, 1997
AQUASIL RIGID SMART WETTING IMPRESSION MATERIAL
K970433
Dentsply Intl.
Dental · 50d
Cleared Mar 19, 1997
CUTTERSIL COMFORT
K965163
Heraeus Kulzer, Inc.
Dental · 85d