FDA 510(k) Applications for Medical Device Product Code "DYW"
(Bracket, Plastic, Orthodontic)
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K081143 |
BIOMERS PRODUCT, LLC |
BIOMERS TRANSLUCENT ORTHODONTIC WIRE |
05/02/2008 |
K110796 |
BIOMERS PRODUCTS, LLC |
SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE |
03/31/2011 |
K182338 |
Blue Sky Bio |
Blue Sky Bio Computerized Orthodontic Bracket System |
11/09/2018 |
K201940 |
Braces on Demand, Inc |
Braces on Demand Bracket |
12/03/2020 |
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 |
K053055 |
GESTENCO INTERNATIONAL AB |
ORTHODONTIC POLYMER COMPOSITE BRACKET |
12/22/2005 |
K150702 |
GREAT LAKES ORTHODONTICS, LTD. |
Exceed Tx |
03/24/2016 |
K981433 |
MIDWEST ORTHODONTIC MFG. |
ORTHODONTIC BRACES |
06/25/1998 |
K150830 |
ORACREW |
CompleClear Plastic Orthodontic Bracket and Wire Appliance |
08/26/2016 |
K101676 |
ORMCO CORP. |
CLEARARCH |
09/13/2010 |
K052477 |
ORMCO CORP. |
DAMON 3 MODIFIED |
11/30/2005 |
K121524 |
ORMCO CORP. |
INSIGNIA |
08/09/2012 |
K123118 |
ORMCO CORP. |
INSIGNIA DIGICAST |
03/26/2013 |
K123416 |
ORMCO CORP. |
INSIGNIA WITH ITERO |
03/13/2013 |
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 |
K180718 |
TOMY, Inc. |
ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES |
10/30/2018 |
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 |
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