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
121–144 of 402
Cleared Apr 03, 2003
P2 POLYETHER
K030318
Heraeus Kulzer, Inc.
Dental · 63d
Cleared Jan 22, 2003
EXAJET
K023751
GC America, Inc.
Dental · 75d
Cleared Dec 18, 2002
OCCLUFAST ROCK
K024034
Zhermack S.P.A.
Dental · 12d
Cleared Dec 18, 2002
ZETAPLUS SOFT
K024041
Zhermack S.P.A.
Dental · 12d
Cleared Dec 13, 2002
TULIP ALGINATE IMPRESSION MATERIAL
K023466
Cavex Holland BV
Dental · 58d
Cleared Oct 28, 2002
ELITE MONOPHASE
K022653
Zhermack S.P.A.
Dental · 80d
Cleared Oct 18, 2002
ISO FUNCTIONAL
K022430
GC America, Inc.
Dental · 85d
Cleared Aug 14, 2002
REGISTRADO X-TRA
K022066
Voco GmbH
Dental · 50d
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 Apr 17, 2002
EMULATE FAST SET AND EMULATE REGULAR SET
K020242
Cavex Holland BV
Dental · 84d
Cleared Nov 01, 2001
CEREC3 VITABLOCKS
K012517
Sirona Dental Systems GmbH
Dental · 87d
Cleared Nov 01, 2001
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL
K012767
S & C Polymer GmbH
Dental · 76d
Cleared Oct 29, 2001
XANTALGIN CRONO
K013336
Cavex Holland BV
Dental · 20d
Cleared Oct 22, 2001
STATUSBLUE
K013237
Dmg USA, Inc.
Dental · 24d
Cleared Oct 17, 2001
LUXABITE
K013236
Dmg USA, Inc.
Dental · 19d
Cleared Sep 04, 2001
EXTRUDE MODIFIED
K012405
Sybron Dental Specialties, Inc.
Dental · 36d
Cleared Jul 19, 2001
CAVEX STABISIL
K011452
Cavex Holland BV
Dental · 69d
Cleared Jul 16, 2001
CAVEX COLORCHANGE
K011419
Cavex Holland BV
Dental · 68d
Cleared Mar 01, 2001
TAKE 1
K003808
Sybron Dental Specialties, Inc.
Dental · 83d
Cleared Feb 15, 2001
PERMLASTIC 3
K003650
Sybron Dental Specialties, Inc.
Dental · 80d
Cleared Feb 01, 2001
FLEXTIME MAGNUM 360
K003930
Heraeus Kulzer, Inc.
Dental · 43d
Cleared Jul 21, 2000
TAKE 1 BITE
K001876
Sybron Dental Specialties, Inc.
Dental · 31d