Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EJF — Predicate Candidate Screening

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

75 daysmedian FDA review time

273 days90th percentile

103clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K994357	BITEM LOCK, MODELS SW006, SW012	Thermoelastic Technologies, Inc.	2000-03-14	78	0
K932825	MICROARCH GOLD BRACKET	Gac Intl., Inc.	1994-05-09	334	0
K933501	ALASTIK	Unitek Corp.	1994-04-28	283	0
K923372	MEMORY WIRE	Althan, Inc.	1994-04-22	652	0
K933080	ORTHOTECH DURA-GOLD BARCKETS	Orthotech	1994-03-23	273	0
K935139	FASCINATION CERAMIC BRACKET	Dentauraum, Inc.	1994-02-04	99	0
K936244	REGENCY BRACKET	Mid-American Dental Specialties, Inc.	1994-02-02	34	0
K934881	REFLECTIONS	Cdb Corp.	1994-02-01	112	0
K935122	DENTAURUM METAL BRACKETS	Dentauraum, Inc.	1994-01-31	95	0
K925028	FORESTADENT ORTHODONTIC BANDS	Forestadent	1994-01-26	481	0
K926427	LARIAT PALATE EXPANDER	Easy Access Orthodontics, Inc.	1994-01-26	399	0
K930881	CHANNEL-EDGE BRACKET SYSTEM	Dualtek, Inc.	1994-01-21	367	0
K933758	REGENCY PLUS BRACKET	Mid-American Dental Specialties, Inc.	1994-01-18	168	0
K922806	ORMCO SPORTSGUARD	Ormco Corp.	1993-10-20	497	0
K925012	PLASTIC CHAIN	American Orthodontics	1993-09-13	346	0
K932025	ION-IMPLANTED NEO SENTALLOY	Gac Intl., Inc.	1993-09-13	140	0
K923218	NITANIUM PALATAL EXPANDER	Ortho Organizers, Inc.	1993-09-13	439	0
K931663	NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL	Ortho Organizers, Inc.	1993-07-08	94	0
K930452	SOLO TIES	Zulaf, Inc.	1993-07-08	162	0
K924971	FORESTADENT BRACKETS	Forestadent Bernhard Forster GmbH	1993-05-27	239	0
K923405	THE HERBST APPLIANCE	Ormco Corp.	1993-05-05	299	0
K923440	APEX DIRECT BONDED BRACKETS	Apex Orthodontics, Inc.	1993-03-31	261	0
K923709	MEMORY WIRE	Wire Products	1993-02-02	190	0
K923261	ORTHODONTIC METAL BRACKET	American Orthodontics	1992-12-03	154	0
K923432	GERMAN MINI DYNALOCK	Unitek Corp.	1992-10-30	109	0
K923029	ORTHODONTIC STAINLESS STEEL BRACKET	Gac Intl., Inc.	1992-09-28	97	0
K923124	GLENROE GOLDEN ORTHODONTIC BRACKET	Glenroe	1992-08-27	62	0
K922499	REFLECTIONS - CERAMIC DENTAL BRACKET	Cdb Corp.	1992-07-30	64	1
K920645	ORTHODONTIC ELASTICS BANDS	Masel Industries, Inc.	1992-07-28	167	0
K914003	MIDAS BRACKET	Gold'N Braces, Inc.	1991-12-16	101	0
K913913	REFURBISHED ORTHODONTIC APPLIANCES	Ortho-Cycle Co.	1991-11-27	89	0
K914616	KLEER(TM) ORTHODONTIC BRACKET	Ormco Corp.	1991-11-20	34	0
K911231	ORTHODONTIC WIRE	Masel Industries, Inc.	1991-10-08	202	0
K912171	PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE	Jack James	1991-08-13	89	0
K910288	NONSTAINING ALASTIKS	Unitek Corp.	1991-03-29	66	0
K903498	RETAINER, SCREW EXPANSION ORTHODONTIC	Masel Industries, Inc.	1991-03-12	221	0
K902809	BRACKET, METAL, ORTHODOTNIC	Masel Industries, Inc.	1990-12-07	163	0
K904092	LANCER ORIGINAL, SIERRA, GENERAL PURPOSE	Lancer Orthodontics, Inc.	1990-11-09	64	0
K904093	BUCCAL TUBE, BUCCAL ATTACHMENT	Lancer Orthodontics, Inc.	1990-11-07	62	0
K904091	TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO	Lancer Orthodontics, Inc.	1990-11-05	60	0
K904089	PERMA MESH	Lancer Orthodontics, Inc.	1990-11-02	57	0
K904094	C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE	Lancer Orthodontics, Inc.	1990-11-02	57	0
K903214	OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS	Medical Fittings, Inc.	1990-09-05	44	0
K902844	NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN	Progressive Dental Supply	1990-09-05	69	0
K902390	AURA CERAMIC DENTAL APPLIANCE	Progressive Technology, Inc.	1990-08-13	75	0
K900678	THE MYOLOC SYSTEM	Winder Research, Inc.	1990-08-13	181	0
K901896	ENDOMETRIAL SAMPLER	Kirwan Surgical Products, Inc.	1990-08-13	110	0
K902064	MODIFIED UNI-STICK PLASTIC LIGATURE	American Orthodontics	1990-08-06	90	0
K902050	BIOLASTIC SUPER ELASTIC ARCHES	Rmo, Inc.	1990-08-03	88	0
K900471	FIBERBRAID(TM) BONDED RETAINER	Uthoff Dental Mfg.	1990-08-02	183	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