EBC · Class II · 21 CFR 872.3765

FDA Product Code EBC: Sealant, Pit And Fissure, And Conditioner

Leading manufacturers include Dentsply Intl., Ultradent Products, Inc. and Pulpdent Corp..

131
Total
131
Cleared
81d
Avg days
1976
Since
131 devices
73–96 of 131
Cleared Oct 23, 1991
PIT AND FISSURE SEALANT PRODUCTS
K914319
Confi-Dental Products Co.
Dental · 27d
Cleared Oct 23, 1991
BARITONE C2 & BARITONE L3
K914322
Confi-Dental Products Co.
Dental · 27d
Cleared Jun 10, 1991
PULPDENT SEAL RITE
K911287
Pulpdent Corp.
Dental · 83d
Cleared Sep 12, 1990
DEGUFILL (TM) WHIT-SEALANT
K902742
Degussa AG
Dental · 82d
Cleared Jul 20, 1990
SEAL RITE(TM)
K902022
Pulpdent Corp.
Dental · 77d
Cleared Jul 13, 1990
SEAL RITE PROCEDURE KIT(TM)
K902023
Pulpdent Corp.
Dental · 70d
Cleared Apr 23, 1990
FLUROSHIELD(TM) VISIBLE LIGHT CURE PIT & FISSURE
K896341
Dentsply Intl.
Dental · 171d
Cleared Mar 14, 1990
TEETHMATE-A
K897027
Kuraray Co.
Dental · 86d
Cleared May 01, 1989
OCCLU-SEAL(TM) VISIBLE LIGHT-CURED FISSURE SEALANT
K891140
Coe Laboratories, Inc.
Dental · 59d
Cleared Feb 08, 1988
MODIFIED PRISMA SHIELD PIT & FISSURE SEALANT
K874944
Dentsply Intl.
Dental · 66d
Cleared Jan 28, 1988
BISCO PIT AND FISSURE SEALANT
K874556
Bisco, Inc.
Dental · 85d
Cleared Jan 28, 1988
BISCO PORCELAIN REPAIR KIT
K874557
Bisco, Inc.
Dental · 85d
Cleared Sep 15, 1987
MODIFIED VISIO-SEAL
K873069
Espe GmbH (Us)
Dental · 40d
Cleared Mar 02, 1987
ALPHA-DENT PIT AND FISSURE SEALANT
K870579
Wallace A. Erickson & Co.
Dental · 20d
Cleared Jul 31, 1986
PRISMA METAL OPAQUERS
K862660
Dentsply Intl.
Dental · 17d
Cleared Jun 23, 1986
SEALITE
K862284
Sybron Corp.
Dental · 7d
Cleared Jan 30, 1986
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
K854882
Lee Pharmaceuticals
Dental · 55d
Cleared Jan 09, 1985
PIT AND FISSURE SEAANTS
K844308
Dentsply Intl.
Dental · 64d
Cleared Jan 07, 1985
CONCISE LIGHT CURED WHITE SEALANT
K844211
3M Company
Dental · 68d
Cleared Sep 27, 1984
COMMAND ULTRASEAL PIT & FISSURE SEALANT
K843024
Kerr Corporation (Danbury)
Dental · 57d
Cleared Sep 07, 1984
APCO FISSURE SEALER & BONDING AGENT
K843098
Scientific Pharmaceuticals, Inc.
Dental · 31d
Cleared Jul 26, 1984
DELTON * OPAQUE LIGHT CURING PIT
K842392
Johnson & Johnson Professionals, Inc.
Dental · 38d
Cleared Jun 30, 1983
DELTON LIGHT CURING PIT & FISSURE
K831380
Johnson & Johnson Professionals, Inc.
Dental · 63d
Cleared Dec 02, 1981
HELIOSEAL
K813015
Vivadent (Usa), Inc.
Dental · 36d