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 American Orthodontics.

194
Total
194
Cleared
80d
Avg days
1976
Since
194 devices
25–48 of 194
Cleared Mar 19, 2004
AEGIS ORTHO DUAL-CURED ORTHODONTIC ADHESIVE
K040547
Harry J. Bosworth Co.
Dental · 17d
Cleared Mar 19, 2004
AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE
K040548
Harry J. Bosworth Co.
Dental · 17d
Cleared Feb 06, 2004
IDEAL 1 ORTHODONTIC BRACKET ADHESIVE
K033703
Dentsply Intl.
Dental · 73d
Cleared Oct 06, 2003
OPTIBAND LC
K032407
Sybron Dental Specialties, Inc.
Dental · 63d
Cleared Sep 29, 2003
ENVISION
K032042
Sybron Dental Specialties, Inc.
Dental · 90d
Cleared May 01, 2002
SOLO ORTHO 3
K020502
Sybron Dental Specialties, Inc.
Dental · 76d
Cleared Apr 26, 2002
GC FUJI ORTHO BAND PASTE PAK
K020578
GC America, Inc.
Dental · 64d
Cleared Mar 14, 2002
PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE
K014133
Pulpdent Corp.
Dental · 87d
Cleared Mar 14, 2002
PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT
K014138
Pulpdent Corp.
Dental · 87d
Cleared Feb 28, 2002
PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM
K020115
Pulpdent Corp.
Dental · 48d
Cleared Feb 27, 2002
PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE
K014059
Pulpdent Corp.
Dental · 79d
Cleared Sep 17, 2001
FIRST SPEP
K012032
Bisco, Inc.
Dental · 80d
Cleared Aug 22, 2000
IMPROVED ENLIGHT LV
K001881
Sybron Dental Specialties, Inc.
Dental · 62d
Cleared Jul 21, 2000
LIGHT-CURED ORTHODONTIC BAND CEMENT
K001446
Scientific Pharmaceuticals, Inc.
Dental · 74d
Cleared Mar 17, 2000
SOLO ORTHO 2
K994309
Sybron Dental Specialties, Inc.
Dental · 87d
Cleared Jun 04, 1999
SOLO ORTHO
K990743
Sybron Dental Specialties, Inc.
Dental · 88d
Cleared Feb 25, 1999
SOLO PLUS ORTHO
K990252
Sybron Dental Specialties, Inc.
Dental · 29d
Cleared Jan 21, 1999
ENLIGHT LV
K984362
Sybron Dental Specialties, Inc.
Dental · 45d
Cleared Jan 20, 1999
ENLIGHT-2
K984217
Sybron Dental Specialties, Inc.
Dental · 57d
Cleared Jun 25, 1998
GC FUJI ORTHO LC
K981461
GC America, Inc.
Dental · 63d
Cleared Sep 16, 1997
ENLIGHT (TENTATIVE NAME)
K972890
Sybron Dental Specialties, Inc.
Dental · 42d
Cleared Sep 03, 1996
ORTHO-ONE
K962946
Bisco, Inc.
Dental · 36d
Cleared May 24, 1996
GC FUJI ORTHO
K961417
GC America, Inc.
Dental · 42d
Cleared Aug 25, 1995
PULPDENT TOUCHDOWN
K953217
Pulpdent Corp.
Dental · 46d