FDA 510(k) Applications for Medical Device Product Code "DYW"
(Bracket, Plastic, Orthodontic)

FDA 510(k) Number Applicant Device Name Decision Date
K874227 ADVANCED ORTHODONTICS SYSTEMS, INC. PLASTIC BRACKETS 12/29/1987
K891372 AMERICAN ORTHODONTICS ORTHODONTIC PLASTIC BRACKET 03/31/1989
K081143 BIOMERS PRODUCT, LLC BIOMERS TRANSLUCENT ORTHODONTIC WIRE 05/02/2008
K110796 BIOMERS PRODUCTS, LLC SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE 03/31/2011
K082207 CADENT, INC. ORTHOCAD IQ 10/23/2009
K973776 CDB CORP. REFLECTIONS 11/21/1997
K052370 DENTSPLY INTERNATIONAL CP BRACKET SYSTEM 11/01/2005
K092030 DENTSPLY INTERNTIONAL ELATION MB METAL REINFORCED PLASTIC BRACKET 07/24/2009
K052714 FDA AGENTS RAVE COMPOSITE BRACKET 10/26/2005
K942826 GAC INTL., INC. ORTHODONITC METAL REINFORCED PLASTIC BRACKET 12/14/1994
K053055 GESTENCO INTERNATIONAL AB ORTHODONTIC POLYMER COMPOSITE BRACKET 12/22/2005
K932920 GLENROE TECHNOLOGIES GLENROE PLASTIC BRACKET 08/24/1993
K150702 GREAT LAKES ORTHODONTICS, LTD. Exceed Tx 03/24/2016
K900809 LEE PHARMACEUTICALS LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS 06/28/1990
K981433 MIDWEST ORTHODONTIC MFG. ORTHODONTIC BRACES 06/25/1998
K150830 ORACREW CompleClear Plastic Orthodontic Bracket and Wire Appliance 08/26/2016
K780239 ORMCO CORP. BRACKET, METAL REINFORCED PLASTIC 03/15/1978
K101676 ORMCO CORP. CLEARARCH 09/13/2010
K052477 ORMCO CORP. DAMON 3 MODIFIED 11/30/2005
K951239 ORMCO CORP. GLOWING SPIRITS 07/19/1995
K121524 ORMCO CORP. INSIGNIA 08/09/2012
K123118 ORMCO CORP. INSIGNIA DIGICAST 03/26/2013
K123416 ORMCO CORP. INSIGNIA WITH ITERO 03/13/2013
K896913 ORMCO CORP. SPIRIT 03/08/1990
K955333 ORMCO CORP. SPIRIT MB 01/04/1996
K160720 ORTHO ORGANIZERS, INC. Carriere Motion Clear Class II 11/28/2016
K140807 ORTHO SPECIALTIES COMPOSITE ORTHODONTIC BRACKETS 11/12/2014
K051953 STICK TECH LTD. EVERSTICK A&O 03/21/2006
K061042 SYBRON DENTAL SPECIALTIES LINGLOCK 01/19/2007
K032408 SYBRON DENTAL SPECIALTIES, INC. DAMON FT 10/15/2003
K943245 SYBRON DENTAL SPECIALTIES, INC. SPIRIT MB 08/23/1994
K050730 ULTRADENT PRODUCTS, INC. MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM 03/31/2005
K071055 ULTRADENT PRODUCTS, INC. OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 05/03/2007
K032625 ULTRADENT PRODUCTS, INC. ORTHODONTIC COMPOSITE BRACKET SYSTEM 02/26/2004
K944286 UNITEK CORP. METAL-LINED TRANSCEND CERAMIC BRACKET 11/29/1994
K861965 UNITEK CORP. UNITEK CERAMIC BRACKET SYSTEM 06/09/1986
K802899 ZULAUF, INC. CERAMIBOND 12/19/1980


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