DYH · Class II · 21 CFR 872.3750

FDA Product Code DYH: Adhesive, Bracket And Tooth Conditioner, Resin

Leading manufacturers include Sybron Dental Specialties, Inc., Ormco Corp. and Pulpdent Corp..

194
Total
194
Cleared
80d
Avg days
1976
Since
194 devices
49–72 of 194
Cleared Jul 14, 1995
PULPDENT GLASS IONOMER CEMENTS
K952854
Pulpdent Corp.
Dental · 23d
Cleared Mar 08, 1995
FUJI ORTHO LC
K950556
GC America, Inc.
Dental · 29d
Cleared Jan 27, 1995
THERMASET
K946255
Ormco Corp.
Dental · 36d
Cleared Mar 31, 1994
SYSTEM 1
K940845
Sybron Dental Specialties, Inc.
Dental · 36d
Cleared Mar 31, 1994
ORMCO SYSTEM 1+ (TM)
K941015
Ormco Corp.
Dental · 28d
Cleared Dec 23, 1992
ADHESIVE, BRACKET AND TOOTH CONDITIONER RESIN
K921283
Jeneric/Pentron, Inc.
Dental · 281d
Cleared Oct 27, 1992
CHALLENGE II - PASTE ADHESIVE
K923399
Ormco Corp.
Dental · 109d
Cleared May 05, 1992
THE BRACKET ASSEMBLY W/ SECURITY SYSTEM II
K921245
Ormco Corp.
Dental · 50d
Cleared Apr 21, 1992
IMPROVED SEQUENCE LIGHT CURE ADHESIVE
K921385
Ormco Corp.
Dental · 29d
Cleared Jan 17, 1992
SEQUENCE LIGHT CURE ADHESIVE
K914727
Ormco Corp.
Dental · 88d
Cleared Jul 05, 1991
PULPDENT ORTHODONTIC BRACKET ADHESIVE
K911286
Pulpdent Corp.
Dental · 108d
Cleared Oct 27, 1989
FORCE II
K895163
American Orthodontics
Dental · 66d
Cleared Jun 23, 1989
AN ALTERNATIVE DIRECT BONDING ORTHO. SYSTEM
K893396
American Orthodontics
Dental · 53d
Cleared Jun 21, 1989
SPECTRUM, VISIBLE LIGHT CURE ORTHODONTIC ADHESIVE
K893255
American Orthodontics
Dental · 54d
Cleared Jun 12, 1989
NO-MIX 30 ORTHODONTIC BONDING SYSTEMS
K893037
American Orthodontics
Dental · 49d
Cleared May 01, 1989
NO-MIX 30 ORTHODONTIC BONDING SYSTEM, PLASTIC
K890834
Scientific Pharmaceuticals, Inc.
Dental · 69d
Cleared Apr 25, 1989
FRS LITE FLUORIDE RELEASING SEALANT
K890740
Ormco Corp.
Dental · 71d
Cleared Oct 12, 1988
ORTHO-SEAL
K883465
Bisco, Inc.
Dental · 58d
Cleared May 18, 1987
ORMCO GEL-ETCH
K871591
Scientific Pharmaceuticals, Inc.
Dental · 24d
Cleared Jan 21, 1987
CHALLENGE ORTHODONTIC BONDING ADHESIVE
K863709
Ormco Corp.
Dental · 120d
Cleared Oct 24, 1986
ACCLAIM* BRACKET ADHESIVE
K864008
Johnson & Johnson Professionals, Inc.
Dental · 9d
Cleared Feb 13, 1986
ESPE NIMETIC-GRIP
K844844
Espe GmbH (Us)
Dental · 427d
Cleared Nov 26, 1985
EXCEL BRACKET ADHESIVE
K854050
Johnson & Johnson Professionals, Inc.
Dental · 54d
Cleared Nov 07, 1985
VISIBLE LIGHT CURED ORTHODONTIC ADHESIVE
K853523
Dentsply Intl.
Dental · 77d