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
73–96 of 195
Cleared Aug 10, 2001
VERTEX L/C ORTHODONTIC DIRECT BONDING PASTE
K010544
Apex Dental Materials, Inc.
Dental · 168d
Cleared Aug 01, 2001
ORTHO VLC
K011521
First Scientific Limited
Dental · 76d
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 Apr 27, 2000
LIGHT BOND (QUICK CURE)
K001048
Reliance Orthodontic Products, Inc.
Dental · 35d
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 Apr 05, 1999
SMARTBOND
K981036
Gac Intl., Inc.
Dental · 382d
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 Mar 28, 1996
RESILIENCE M5 PROTECTION PLUS
K955329
Confi-Dental Products Co.
Dental · 129d
Cleared Oct 19, 1995
AMERICAN DENTAL PRODUCTS PASTE-PRIMER ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
K954373
American Dental Products, Inc.
Dental · 30d
Cleared Oct 19, 1995
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE, TWO PASTE BONDING SYSTEM
K954374
American Dental Products, Inc.
Dental · 30d
Cleared Oct 17, 1995
AMERICAN DENTAL PRODUCTS TWO PASTE ADHESIVE ORTHODONTIC BONDING SYSTEM W/FLUORIDE
K954372
American Dental Products, Inc.
Dental · 28d
Cleared Oct 12, 1995
AMERICAN DENTAL PRODUCTS LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTEM W/FLUORIDE
K954244
American Dental Products, Inc.
Dental · 31d
Cleared Oct 12, 1995
AMERICAN DENTAL PRODUCTS ORTHODONTIC ADHESIVE W/ONE STEP BONDING SYSTEM
K954333
American Dental Products, Inc.
Dental · 24d
Cleared Sep 12, 1995
LIGHT-CURE PC
K952856
Midwest Orthodontic Mfg.
Dental · 82d
Cleared Sep 08, 1995
PC-LOCK
K952855
Midwest Orthodontic Mfg.
Dental · 78d
Cleared Sep 05, 1995
PRO-LOCK
K952857
Midwest Orthodontic Mfg.
Dental · 75d