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
265–288 of 402
Cleared Jun 11, 1987
VINYL POLYSILOXANE IMPRESSION SYSTEM
K871409
Crown Delta Corp.
Dental · 64d
Cleared Dec 01, 1986
HYDROPHILIC REPROSIL
K863288
Dentsply Intl.
Dental · 98d
Cleared Sep 25, 1986
NEW LIGHT-CURING IMPRESSION MATERIAL
K862879
Dentsply Intl.
Dental · 57d
Cleared Mar 26, 1986
AUSTENAL HYCO ALGINATE IMPRESSION MATERIAL
K860911
Austenal Dental, Inc.
Dental · 15d
Cleared Mar 20, 1986
KERR POL-E-LASTIC DENTAL IMPRESSION MATERIAL
K860532
Kerr Corporation (Danbury)
Dental · 36d
Cleared Mar 17, 1986
IMPREGUM-F
K853529
Espe GmbH (Us)
Dental · 206d
Cleared Mar 17, 1986
BAYSILEX
K854106
Cutter Laboratories, Inc.
Dental · 160d
Cleared Mar 17, 1986
POLYJEL N.F. (NEW FORMULA)
K860146
Dentsply Intl.
Dental · 61d
Cleared Jan 30, 1986
PROOF ALGINATE IMPRESSION MATERIAL
K854855
Sybron Corp.
Dental · 56d
Cleared May 29, 1985
SEPTOSIL SILICONE FOR PRECISION IMPRESSION
K851388
Specialites Septodont
Dental · 50d
Cleared May 01, 1985
76 ELW BITE CHECKER SILICONE
K851469
G-C Intl. Corp.
Dental · 15d
Cleared Mar 11, 1985
ABSOLUTE VINYL POLYSILOXANE IMPRESS
K842877
Coe Laboratories, Inc.
Dental · 231d
Cleared Dec 03, 1984
SURFLEX F
K844329
G-C Intl. Corp.
Dental · 26d
Cleared Nov 09, 1984
PERFOURM
K842324
Cutter Laboratories, Inc.
Dental · 149d
Cleared Oct 18, 1984
TWO COMPONENT RTV VINYL SILICONE MATER
K843145
Crown Delta Corp.
Dental · 69d
Cleared Apr 06, 1983
ODONTIC CENTRIC(BITE) REGIST. PASTE
K830044
Wallace A. Erickson & Co.
Dental · 89d
Cleared Jun 07, 1982
DENTAL IMPRESSION MATERIAL
K821221
Crown Delta Corp.
Dental · 41d
Cleared Feb 24, 1982
SYBRON/KERR MIRROR 3
K820183
Sybron Corp.
Dental · 33d
Cleared Oct 06, 1981
EXAFLEX IMPRESSION MATERIAL
K812406
G-C Intl. Corp.
Dental · 46d
Cleared Oct 06, 1981
G-C FIT-CHECKER IMPRESSION MATERIAL
K812679
G-C Intl. Corp.
Dental · 14d
Cleared Oct 02, 1981
SR-ALGICAP
K811867
J. Aderer, Inc.
Dental · 93d
Cleared Apr 14, 1981
SR-IVOSEAL
K810523
J. Aderer, Inc.
Dental · 47d
Cleared Oct 10, 1980
ALGINATE IMPRESSION MATERIAL
K802362
Dentsply Intl.
Dental · 14d
Cleared Jul 21, 1980
ASH BLUEPRINT ALGINATE IMPRESSION MATER.
K801587
Dentsply Intl.
Dental · 10d