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

DZB — Predicate Candidate Screening

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

82 daysmedian FDA review time

240 days90th percentile

36clearances measured

K-number	Device	Applicant	Decided	Review days
K202855	Orthodontic Facemask	Ita.O Italian Orthodontic System S.R.L.	2021-06-21	266
K162543	Reverse Pull Adjustable Facemask	Sawbros Industries Pvt., Ltd.	2017-08-28	350
K111169	PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS,	Kwang Myung Daicom, Inc.	2011-10-03	160
K103019	KJ MASK	Kj Meditech Co., Ltd.	2011-06-09	240
K052553	NITOM LOCKING FACEBOW	Russell Samuels Orthodontic Design	2005-12-22	97
K051751	EQUA-PULL SAFETY RELEASE MODULE	Ortho Technology	2005-07-22	23
K041718	KELES FACEMASK	Great Lakes Orthodontics, Ltd.	2004-10-15	113
K032392	MORALES PROTRACTION FACEMASK	Ortosim, S.A. DE C.V.	2003-10-22	79
K000358	MULTI ADJUSTABLE FACE MASK	Ortho Technology	2000-06-09	126
K993224	T-GEAR, MODEL TG/400-700	Dontech Products B.V.	2000-02-11	137
K982088	AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE	Ortho Kinetics Corp.	1998-09-04	81
K980436	CLASS III REVERSE PULL FACEMASK	Ortho Kinetics Corp.	1998-04-27	82
K980245	NITOM LOCKING FACEBOW	Ortho Kinetics Corp.	1998-04-21	88
K980151	RELEASABLE FORCE MODULE	Ortho Kinetics Corp.	1998-04-06	80
K980195	FACEBOW	Ortho Kinetics Corp.	1998-03-11	50
K961754	SAFETY RELEASE MODULE	G & H Wire Co.	1996-07-10	65
K955528	CLP BONNET	Clp Products	1996-02-14	72
K950121	FRANCE ORTHODONTIE	France Orthodontie	1995-03-08	55
K936151	EXTRAORAL HEADGEAR	Dentauraum, Inc.	1994-08-01	217
K940410	NEW GEAR RELEASABLE HEADGEAR	Ortho Kinetics Corp.	1994-03-10	42
K932761	SOFT-WEAR HEADGEAR AND SAFETY MODULES	Professional Positioners, Inc.	1993-10-07	121
K925240	FACEBOW	Forestadent Bernhard Forster GmbH	1993-06-18	245
K923556	ADP FACEMASK	Ormco Corp.	1992-12-04	140
K920784	ORTHODONTIC FACE BOW W/ INNER WIRE	Gac Intl., Inc.	1992-03-20	29
K912682	ORTHODONTIC HEADGEAR	K-Tek Orthodontic Products	1991-12-09	179
K902646	HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP	Ormco Corp.	1990-09-06	83
K902645	HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL	Ormco Corp.	1990-09-06	83
K901958	GUARDIAN SAFE BOW	Lancer Orthodontics, Inc.	1990-07-30	90
K862538	SENTRY BREAKWAY NECK STRAP	Ormco Corp.	1986-07-11	9
K861424	ADAPTABLE CLASS III MASK	Great Lakes Orthodontics, Ltd.	1986-05-29	43
K852670	A-COMPANY ESPREE SAFETY HEADGEAR	A Company, Inc.	1985-07-31	37
K800748	SNAP-WAY HEADGEAR	Northwest Orthodontics, Inc.	1980-04-10	6
K790843	SNAP-WAY	Northwest Orthodontics, Inc.	1979-05-31	29
K780747	SNAP-WAY	Northwest Orthodontics, Inc.	1978-05-26	18
K771706	SAIF-BOW	Northwest Orthodontics, Inc.	1977-09-20	11
K771095	J HOOK HEADGEAR	Northwest Orthodontics, Inc.	1977-06-24	4

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