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
289–312 of 402
Cleared Jul 08, 1980
CROWN DELTA SILICONE IMPRESSION MATERIAL
K801380
Crown Delta Corp.
Dental · 27d
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 Jun 15, 1979
IMPRESSION MATERIAL, RUBBER
K790592
Wallace A. Erickson & Co.
Dental · 81d
Cleared Jun 15, 1979
DENTAL ALGINATE IMPRESSION MATERIAL
K790595
Wallace A. Erickson & Co.
Dental · 81d
Cleared Feb 21, 1979
ZYLOX
K782139
Premier Dental Products Co.
Dental · 56d
Cleared Nov 15, 1978
REFLECT IMPRESSION MATERIAL
K781689
Kerr Corporation (Danbury)
Dental · 42d
Cleared Aug 31, 1978
DENTAL SILICONE IMPRESSION MATERIAL
K781083
Crown Delta Corp.
Dental · 63d
Cleared Aug 31, 1978
REPROSIL
K781151
Dentsply Intl.
Dental · 52d
Cleared May 31, 1978
RTV SILICONE HAND KNEADABLE PUTTY
K780778
Crown Delta Corp.
Dental · 20d
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
Cleared Jul 21, 1976
PUTTY, ACCOE
K760225
Coe Laboratories, Inc.
Dental · 9d
Cleared Jul 21, 1976
PASTE, ACCOE IMPRESSION
K760226
Coe Laboratories, Inc.
Dental · 9d
Cleared Jul 21, 1976
IMPRESSION MATERIAL, DENTAL SILICON RTV
K760231
Crown Delta Corp.
Dental · 7d