Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DYW — Predicate Candidate Screening

42 FDA 510(k) clearances under this product code; the 50 most recent screened below.

78 daysmedian FDA review time

257 days90th percentile

42clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K252760	Carriere® Motion Pro® Clear Bite Corrector	Ortho Organizers, Inc.	2025-11-27	90	0
K251196	Composite Orthodontic Brackets and Buttons	Ec Certification Service GmbH	2025-04-21	4	0
K201940	Braces on Demand Bracket	Braces on Demand, Inc.	2020-12-03	143	0
K182338	Blue Sky Bio Computerized Orthodontic Bracket System	Blue Sky Bio	2018-11-09	73	0
K180718	ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES	Tomy, Inc.	2018-10-30	225	0
K160720	Carriere Motion Clear Class II	Ortho Organizers, Inc.	2016-11-28	257	0
K150830	CompleClear Plastic Orthodontic Bracket and Wire Appliance	Oracrew	2016-08-26	515	0
K150702	Exceed Tx	Great Lakes Orthodontics, Ltd.	2016-03-24	372	0
K140807	COMPOSITE ORTHODONTIC BRACKETS	Ortho Specialties	2014-11-12	225	0
K123118	INSIGNIA DIGICAST	Ormco Corp.	2013-03-26	174	0
K123416	INSIGNIA WITH ITERO	Ormco Corp.	2013-03-13	127	0
K121524	INSIGNIA	Ormco Corp.	2012-08-09	78	0
K110796	SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE	Biomers Products, LLC	2011-03-31	9	0
K101676	CLEARARCH	Ormco Corp.	2010-09-13	90	0
K082207	ORTHOCAD IQ	Cadent, Inc.	2009-10-23	444	0
K092030	ELATION MB METAL REINFORCED PLASTIC BRACKET	Dentsply Interntional	2009-07-24	18	0
K081143	BIOMERS TRANSLUCENT ORTHODONTIC WIRE	Biomers Product, LLC	2008-05-02	10	0
K071055	OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 26	Ultradent Products, Inc.	2007-05-03	17	0
K061042	LINGLOCK	Sybron Dental Specialties	2007-01-19	280	0
K051953	EVERSTICK A&O	Stick Tech , Ltd.	2006-03-21	246	0
K053055	ORTHODONTIC POLYMER COMPOSITE BRACKET	Gestenco International AB	2005-12-22	52	0
K052477	DAMON 3 MODIFIED	Ormco Corp.	2005-11-30	82	2
K052370	CP BRACKET SYSTEM	Dentsply International	2005-11-01	63	0
K052714	RAVE COMPOSITE BRACKET	FDA Agents	2005-10-26	27	0
K050730	MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM	Ultradent Products, Inc.	2005-03-31	10	0
K032625	ORTHODONTIC COMPOSITE BRACKET SYSTEM	Ultradent Products, Inc.	2004-02-26	184	0
K032408	DAMON FT	Sybron Dental Specialties, Inc.	2003-10-15	72	0
K981433	ORTHODONTIC BRACES	Midwest Orthodontic Mfg.	1998-06-25	66	0
K973776	REFLECTIONS	Cdb Corp.	1997-11-21	49	0
K955333	SPIRIT MB	Ormco Corp.	1996-01-04	44	0
K951239	GLOWING SPIRITS	Ormco Corp.	1995-07-19	121	0
K942826	ORTHODONITC METAL REINFORCED PLASTIC BRACKET	Gac Intl., Inc.	1994-12-14	183	0
K944286	METAL-LINED TRANSCEND CERAMIC BRACKET	Unitek Corp.	1994-11-29	88	0
K943245	SPIRIT MB	Sybron Dental Specialties, Inc.	1994-08-23	48	3
K932920	GLENROE PLASTIC BRACKET	Glenroe Technologies	1993-08-24	70	0
K900809	LEE-FISCHER CERAMIC REINFORCED PLASTIC BRACKETS	Lee Pharmaceuticals	1990-06-28	127	0
K896913	SPIRIT	Ormco Corp.	1990-03-08	87	0
K891372	ORTHODONTIC PLASTIC BRACKET	American Orthodontics	1989-03-31	22	0
K874227	PLASTIC BRACKETS	Advanced Orthodontics Systems, Inc.	1987-12-29	74	0
K861965	UNITEK CERAMIC BRACKET SYSTEM	Unitek Corp.	1986-06-09	21	0
K802899	CERAMIBOND	Zulauf, Inc.	1980-12-19	32	0
K780239	BRACKET, METAL REINFORCED PLASTIC	Ormco Corp.	1978-03-15	30	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda