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
97–120 of 131
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 Jul 31, 1986
FLUOR-ETCH GEL ETCHANT
K862695
Teledyne, Inc.
Dental · 16d
Cleared Jun 23, 1986
SEALITE
K862284
Sybron Corp.
Dental · 7d
Cleared Apr 11, 1986
ORTHOSOURCE ETCH SYSTEMS
K861245
Ortho Source
Dental · 9d
Cleared Jan 30, 1986
PROTEC/VISIBLE LIGHT-CURED SEALANT/DENTAL RESTORAT
K854882
Lee Pharmaceuticals
Dental · 55d
Cleared Dec 23, 1985
CERAM-ETCH
K854494
Gresco Products, Inc.
Dental · 41d
Cleared Mar 18, 1985
FOREMOST LITE CURE PIT & FISSURE SEALANT
K845034
Foremost Dental Mfg., Inc.
Dental · 81d
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 Dec 03, 1984
C-22 PIT & FISSURE SEALANT
K844057
Pentron Corp.
Dental · 46d
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
Cleared Nov 24, 1981
FISSURE SEALER & BONDING AGENT
K813091
Sci-Pharm, Inc.
Dental · 22d
Cleared Sep 25, 1981
BEAUSEAL
K812549
Sci-Pharm, Inc.
Dental · 21d
Cleared Jun 26, 1981
VISIO-SEAL
K811624
Espe-Premier Sales Co.
Dental · 17d
Cleared Apr 29, 1981
VISIO-SEAL
K810950
Espe Dental Products
Dental · 22d