DYW · Class II · 21 CFR 872.5470

FDA Product Code DYW: Bracket, Plastic, Orthodontic

Leading manufacturers include Ormco Corp., Ultradent Products, Inc. and Unitek Corp..

42
Total
42
Cleared
118d
Avg days
1978
Since
42 devices
25–42 of 42
Cleared Mar 31, 2005
MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM
K050730
Ultradent Products, Inc.
Dental · 10d
Cleared Feb 26, 2004
ORTHODONTIC COMPOSITE BRACKET SYSTEM
K032625
Ultradent Products, Inc.
Dental · 184d
Cleared Oct 15, 2003
DAMON FT
K032408
Sybron Dental Specialties, Inc.
Dental · 72d
Cleared Jun 25, 1998
ORTHODONTIC BRACES
K981433
Midwest Orthodontic Mfg.
Dental · 66d
Cleared Nov 21, 1997
REFLECTIONS
K973776
Cdb Corp.
Dental · 49d
Cleared Jan 04, 1996
SPIRIT MB
K955333
Ormco Corp.
Dental · 44d
Cleared Jul 19, 1995
GLOWING SPIRITS
K951239
Ormco Corp.
Dental · 121d
Cleared Nov 29, 1994
METAL-LINED TRANSCEND CERAMIC BRACKET
K944286
Unitek Corp.
Dental · 88d
Cleared Aug 23, 1994
SPIRIT MB
K943245
Sybron Dental Specialties, Inc.
Dental · 48d
Cleared Jun 28, 1990
LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS
K900809
Lee Pharmaceuticals
Dental · 127d
Cleared Mar 08, 1990
SPIRIT
K896913
Ormco Corp.
Dental · 87d
Cleared Mar 31, 1989
ORTHODONTIC PLASTIC BRACKET
K891372
American Orthodontics
Dental · 22d
Cleared Jun 09, 1986
UNITEK CERAMIC BRACKET SYSTEM
K861965
Unitek Corp.
Dental · 21d
Cleared Mar 15, 1978
BRACKET, METAL REINFORCED PLASTIC
K780239
Ormco Corp.
Dental · 30d