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

DZC — Predicate Candidate Screening

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

126 daysmedian FDA review time

188 days90th percentile

30clearances measured

K-number	Device	Applicant	Decided	Review days
K112640	HYPERELASTIC WIRE	Ormco Corp.	2011-11-16	65
K943334	HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT	Jay H. Geller	1994-10-05	85
K935638	NITINOL, NITI	Highland Metals	1994-05-18	176
K935140	DENTAURUM STEEL LIGATURE WIRES	Dentauraum, Inc.	1994-02-04	99
K935142	DENTAURUM WIRES	Dentauraum, Inc.	1994-01-31	95
K934265	FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE	Flexmedics	1994-01-21	143
K933374	NITI COIL SPRINGS	Highland Metals	1993-11-19	133
K933377	STAINLESS STEEL ARCHES REPACKER RELABETER	Highland Metals	1993-11-16	130
K933378	REVERSE CURVE NITI ARCH WIRE REPACKER RELABETER	Highland Metals	1993-11-12	126
K933380	REVERSE SURVE NITI ARCH WIRE	Highland Metals	1993-11-12	126
K933379	STAINLESS STEEL ARCHES	Highland Metals	1993-11-12	126
K933376	NITI ARCH WIRE ON A SPOOL	Highland Metals	1993-11-12	126
K931631	COATED ORTHODONTIC DEVICES	Wonder Wire	1993-07-28	117
K930202	TITAN SEPARATING SPRING	Ortho Spectrum, Inc.	1993-05-27	133
K924805	ORTHODONTIC ARCH WIRE	Ultimate Wireforms, Inc.	1993-03-31	188
K923837	DIMPLED MULTI MODULUS ARCH WIRE	Ultimate Wireforms, Inc.	1993-03-31	244
K923836	.016' X .016 NICKEL TITANIUM UPRIGHTING SPRING	Ultimate Wireforms, Inc.	1992-12-23	146
K923838	THE ULTIMATE RCS ARCH WIRE	Ultimate Wireforms, Inc.	1992-12-04	127
K920905	BIOFORCE WIRE	Gac Intl., Inc.	1992-11-04	251
K923839	NITINOL GENTLE TOUCH COIL SPRING	Ultimate Wireforms, Inc.	1992-10-15	77
K920850	GAC THUMB-SUCKING CONTROL APPLIANCE	Gac Intl., Inc.	1992-08-24	181
K863742	FLEXMEDICS NITINOL ARCH WIRE	Flexmedics	1986-11-24	62
K852975	INTERPORE 200 POROUS HYDROXYAPATITE	Inrterpore Intl.	1985-10-31	108
K851878	A COMPANY BRASS SEPARATING RINGS	A Company, Inc.	1985-06-05	37
K851055	SENTINOL -ORTHODONTIC ARCH WIRE	Gac Intl., Inc.	1985-05-09	56
K843171	FILAFEX TM, ESTHETIC ORTHODONTIC WIRE	Berkley and Co.	1984-12-03	112
K843722	ORTHODONTIC WIRE	Arthur L. Wool	1984-11-09	46
K841638	ALINE ORTHODONTIC ARCHWIRE	A Company, Inc.	1984-06-27	68
K833788	FILAFEX ESTHETIC ORTHODINIC WIRE	Berkley and Co.	1984-01-24	85
K812454	PAC-AID	Albert J. Anthony, Dmd	1981-09-23	26

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