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..

195
Total
195
Cleared
80d
Avg days
1976
Since
195 devices
25–48 of 195
Cleared Feb 02, 2012
APC FLASH-FREE ADHESIVE
K113197
3M Unitek Corporation
Dental · 94d
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 Jul 27, 2010
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
K100536
3M Unitek
Dental · 152d
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 Oct 30, 2009
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II
K093221
Dentsply Intl., Inc.
Dental · 17d
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 Jul 16, 2008
LION SE ONE STEP ORTHODONTIC ADHESIVE
K080445
Classone Orthodontics, Inc.
Dental · 148d
Cleared Jun 11, 2008
GC OPB-100
K080724
GC America, Inc.
Dental · 89d
Cleared May 22, 2008
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION
K081291
Dentsply Interntional
Dental · 15d
Cleared Feb 15, 2008
GC MODELS OPA-100 AND JC-50
K073588
GC America, Inc.
Dental · 57d
Cleared Feb 15, 2008
TRANSBOND SUPREME ADHESIVE
K073697
3M Unitek
Dental · 46d
Cleared Jan 17, 2008
TENDER ORTHO BOND-ENA BOND-ENA ETCH
K072978
Micerium S.P.A.
Dental · 87d
Cleared Dec 04, 2007
RM BOND, MODEL J032
K072830
Pentron Clinical Technologies
Dental · 62d
Cleared Jul 31, 2007
THERMA-CURE
K071590
Reliance Orthodontic Products, Inc.
Dental · 50d
Cleared Feb 12, 2007
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM
K061252
Primus Consulting
Dental · 284d
Cleared Jul 06, 2006
GRENGLOO
K061481
Ormco Corp.
Dental · 37d
Cleared Jan 25, 2006
RELI-ON ONE STEP, ORTHODONTIC ADHESIVE
K053379
Classone Orthodontics, Inc.
Dental · 51d
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