ELW · Class II · 21 CFR 872.3660

FDA Product Code ELW: Material, Impression

Leading manufacturers include Dentsply Intl., Heraeus Kulzer, Inc. and GC America, Inc..

402
Total
402
Cleared
95d
Avg days
1976
Since
402 devices
121–144 of 402
Cleared Aug 11, 1988
IMPRINT VINYL POLYSILOXANE IMPRESSION MATERIAL
K882690
3M Company
Dental · 42d
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 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 Nov 09, 1984
PERFOURM
K842324
Cutter Laboratories, Inc.
Dental · 149d
Cleared Feb 24, 1982
SYBRON/KERR MIRROR 3
K820183
Sybron Corp.
Dental · 33d
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
Cleared Mar 18, 1980
VINYL POLYSILOXANE IMPRESSION MATERIAL
K800485
3M Company
Dental · 14d
Cleared Mar 18, 1980
SUPERSIL
K800548
Harry J. Bosworth Co.
Dental · 8d
Cleared Jan 09, 1980
SILAGUM
K792363
Parkell, Inc.
Dental · 47d
Cleared Feb 21, 1979
ZYLOX
K782139
Premier Dental Products Co.
Dental · 56d
Cleared Aug 31, 1978
REPROSIL
K781151
Dentsply Intl.
Dental · 52d
Cleared Oct 13, 1977
PERMAGUM ADHESIVE
K771853
Espe GmbH (Us)
Dental · 14d
Cleared Sep 02, 1977
PERMAGUM
K771627
Espe GmbH (Us)
Dental · 7d
Cleared Oct 20, 1976
CUTTER JEL-ALGINATE IMPRESSION MAT.
K760753
Cutter Laboratories, Inc.
Dental · 19d
Cleared Oct 15, 1976
CUTTER FLEX-SILICONE IMPRESSION MAT.
K760752
Cutter Laboratories, Inc.
Dental · 14d
Cleared Oct 15, 1976
CUTTER SIL-SILICONE IMPRESSION MAT
K760755
Cutter Laboratories, Inc.
Dental · 14d