DYH · Class II · 21 CFR 872.3750

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

Leading manufacturers include Reliance Orthodontic Products, Inc., Sybron Dental Specialties, Inc. and Ormco Corp..

194
Total
194
Cleared
80d
Avg days
1976
Since
194 devices
25–48 of 194
Cleared Sep 14, 2011
PADLOCK
K111814
Reliance Orthodontic Products, Inc.
Dental · 79d
Cleared Sep 07, 2011
OPAL BAND CEMENT
K111696
Ultradent Products, Inc.
Dental · 82d
Cleared Oct 26, 2010
LIGHT CURE RETAINER
K101951
Reliance Orthodontic Products, Inc.
Dental · 106d
Cleared Apr 29, 2010
OPAL BOND FLOW
K100301
Ultradent Products, Inc.
Dental · 85d
Cleared Mar 23, 2010
OPAL BOND MV
K094006
Ultradent Products, Inc.
Dental · 85d
Cleared Apr 29, 2009
OPAL SEAL
K090355
Ultradent Products, Inc.
Dental · 77d
Cleared Feb 20, 2009
FLOWTAIN & FLOWTAIN LV
K083051
Reliance Orthodontic Products, Inc.
Dental · 129d
Cleared Jun 11, 2008
GC OPB-100
K080724
GC America, Inc.
Dental · 89d
Cleared Feb 15, 2008
GC MODELS OPA-100 AND JC-50
K073588
GC America, Inc.
Dental · 57d
Cleared Jul 31, 2007
THERMA-CURE
K071590
Reliance Orthodontic Products, Inc.
Dental · 50d
Cleared Jul 06, 2006
GRENGLOO
K061481
Ormco Corp.
Dental · 37d
Cleared Apr 06, 2005
LC BRACKET ADHESIVE SYSTEM
K050750
Dentsply Intl.
Dental · 14d
Cleared Nov 15, 2004
D3 CHROMA
K042422
Sybron Dental Specialties, Inc.
Dental · 69d
Cleared Apr 02, 2004
IDEAL 1 ORTHODONTIC BAND CEMENT
K040375
Dentsply Intl.
Dental · 45d
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 Dec 16, 2003
EVOLVE
K033551
Reliance Orthodontic Products, Inc.
Dental · 36d
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 Aug 20, 2003
S & C -BRACKET ADHESIVES
K031420
S & C Polymer GmbH
Dental · 107d
Cleared Mar 12, 2003
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K030036
Pulpdent Corporation
Dental · 68d
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