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
49–72 of 131
Cleared Oct 22, 1999
NRC NON-RINSE CONDITIONER
K992519
Dentsply Intl.
Dental · 86d
Cleared Oct 08, 1999
3M CLINPRO SEALANT
K992326
3M Company
Dental · 87d
Cleared Sep 22, 1999
PRIME & BOND NT DUAL CURE UNIVERSAL DENTAL ADHESIVE SYSTEM
K992518
Dentsply Intl.
Dental · 56d
Cleared Aug 27, 1999
DYRACT SEAL COMPOMER PIT & FISSURE SEALANT
K992516
Dentsply Intl.
Dental · 30d
Cleared Aug 20, 1999
DELTON FS WITH FLUORIDE PIT & FISSURE SEALANT
K991909
Dentsply Intl.
Dental · 74d
Cleared Jul 26, 1999
LC PIT & FISSURE SEALANT
K991902
Bosworth Co.
Dental · 52d
Cleared Jun 10, 1999
AMERICAN DENTAL PRODUCTS ETCH-DETECT
K991099
American Dental Products, Inc.
Dental · 70d
Cleared May 14, 1999
CONSEAL F
K990650
Southern Dental Industries, Inc.
Dental · 74d
Cleared Mar 03, 1999
HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025
K990306
Kay See Dental Mfg. Co.
Dental · 30d
Cleared Oct 06, 1998
DELTON FS DIRECT DELIVERY SYSTEM
K982564
Dentsply Intl.
Dental · 75d
Cleared Nov 25, 1997
MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED
K973541
Medental Intl.
Dental · 68d
Cleared Mar 27, 1997
TEETHMATE F-1
K965091
Kuraray Company, Ltd.
Dental · 98d
Cleared Nov 12, 1996
PULPDENT SEAL-RITE UDMA
K963921
Pulpdent Corp.
Dental · 43d
Cleared Apr 23, 1996
GLY-ETCH
K961190
Centrix, Inc.
Dental · 28d
Cleared Mar 08, 1996
IONOSIT SEAL
K954867
Foremost Dental Mfg., Inc.
Dental · 136d
Cleared Jan 04, 1996
SEALITE FL
K954827
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared Oct 30, 1995
AMERICAN DENTAL PRODUCTS PIT & FISSUE SEALANT LIGHT CURING
K954701
American Dental Products, Inc.
Dental · 18d
Cleared Aug 18, 1995
TOOTH PREPARATION CONDITIONER, PRE-IMPRESSION
K952240
Jeneric/Pentron, Inc.
Dental · 98d
Cleared May 03, 1995
DELTON F PIT & FISSURE SEALANT
K951296
Dentsply Intl.
Dental · 42d
Cleared Jan 17, 1995
PULPDENT CHEMICAL CURE PIT AND FISSURE SEALANT
K945378
Pulpdent Corp.
Dental · 76d
Cleared Jan 21, 1994
P&FS PIT AND FISSURE SEALANT
K935727
Jedental Co., Inc.
Dental · 51d
Cleared Sep 20, 1993
PULPDENT SEAL-RITE LOW VISCOSITY
K932794
Pulpdent Corp.
Dental · 103d
Cleared Sep 15, 1993
HELIOSEAL F
K932078
Ivoclar North America, Inc.
Dental · 139d
Cleared Jul 22, 1993
SUPPLEMENTAL FORMULA TO BARITONE L3 SEALANT
K931857
Confi-Dental Products Co.
Dental · 100d