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
97–120 of 402
Cleared Jan 03, 2006
EXPASYL POWER APPLICATOR
K051933
Sybron Dental Specialties, Inc.
Dental · 174d
Cleared Nov 23, 2005
IMPRESSIX
K052455
Cavex Holland BV
Dental · 77d
Cleared Jul 21, 2005
FUTURE WASH/YPS
K051797
3M Espe AG Dental Products
Dental · 16d
Cleared Jul 19, 2005
ELITE IMPLANT
K050417
Zhermack S.P.A.
Dental · 151d
Cleared Jul 15, 2005
HYDROGUM 5
K051424
Zhermack S.P.A.
Dental · 44d
Cleared Jun 28, 2005
MODIFICATION TO:REGISTRADO X-TRA
K051535
Voco GmbH
Dental · 18d
Cleared Jun 23, 2005
JET BLUE BITE
K051243
Coltene/Whaledent AG
Dental · 41d
Cleared Jun 21, 2005
CAVEX ORTHOTRACE
K051207
Cavex Holland BV
Dental · 41d
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 Feb 18, 2005
GENIE MAGIC MIX ULTRA HYDROPHILIC IMPRESSION MATERIAL
K043054
Sultan Chemists, Inc.
Dental · 105d
Cleared Feb 09, 2005
RETRACTOFOAM
K050013
Coltene/Whaledent AG
Dental · 37d
Cleared Jan 27, 2005
FUSION FAST
K043471
GC America, Inc.
Dental · 42d
Cleared Jan 24, 2005
HYDROGUM SOFT
K043118
Zhermack S.P.A.
Dental · 75d
Cleared Dec 17, 2004
FLEXITIME XTREME
K042878
Heraeus Kulzer, Inc.
Dental · 60d
Cleared Dec 15, 2004
TORPICALGIN
K043131
Zhermack S.P.A.
Dental · 33d
Cleared Dec 03, 2004
CORRECT DENTAL IMPRESSION MATERIAL
K042860
Handae Chemical Co., Ltd.
Dental · 49d
Cleared Jun 25, 2004
GC FUSION
K041398
GC America, Inc.
Dental · 30d
Cleared Jun 17, 2004
MULTIPLE (ADDITION SILICONE IMPRESSION MATERIAL)
K041229
Cosmedent, Inc.
Dental · 38d
Cleared May 14, 2004
CROWN DELTA HYDROPHILIC IMPRESSION MATERIAL
K041028
Crown Delta Corp.
Dental · 23d
Cleared Oct 20, 2003
FIT CHECKER II
K032289
GC America, Inc.
Dental · 88d
Cleared Oct 02, 2003
ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR)
K031439
Harry J. Bosworth Co.
Dental · 149d
Cleared Sep 30, 2003
TULIP COLORSWITCH
K032116
Cavex Holland BV
Dental · 83d
Cleared Aug 11, 2003
POLY Q (GARANT L, PENTA M, PENTA H)
K032001
3M Espe AG Dental Products
Dental · 45d