Coe Laboratories, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
20
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K903292ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALSOctober 19, 1990
K894282FIRST IMPRESSION TMDecember 22, 1989
K894281FIRST IMPRESSION WITH CHLORHEXIDINESeptember 26, 1989
K891140OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANTMay 1, 1989
K885010TRIPTON(TM) VISIBLE LIGHT-CURED UNIV. BONDINGFebruary 13, 1989
K881422COE PAK AUTO MIX, REGULAR OR HARD SETOctober 31, 1988
K881091OMNISIL, VINYL POLYSILOXANE IMPRESSION MATERIALJune 28, 1988
K863882OPALUX VISIBLE LIGHT CURED ANTERIOR COMPOSITENovember 18, 1986
K842877ABSOLUTE VINYL POLYSILOXANE IMPRESSMarch 11, 1985
K844325COE-LITE POLYMERIZATION UNITDecember 11, 1984
K844326OCCLUSIN LIGHT CURED VISIBLE RADIOPAQUE COMPOSITEDecember 3, 1984
K830294MEDICAL EXAM TABLEJanuary 11, 1984
K833261INTERIM TEMP. CROWN & BRIDGE RESINJanuary 3, 1984
K831575NU-CAP CALCIUM HYDROX. PULP CAPPINGJune 30, 1983
K820673SELF-CURING HARD DENTURE LINERApril 9, 1982
K792428COE-SILJanuary 23, 1980
K792427PERMA-CRYL 20December 13, 1979
K771615AUDI-SIL EARMOLD MATERIALAugust 30, 1977
K760225PUTTY, ACCOEJuly 21, 1976
K760226PASTE, ACCOE IMPRESSIONJuly 21, 1976