Headgear, Extraoral, Orthodontic

FDA product code DZB · Class II (moderate risk) · 21 CFR 872.5500 · Dental

36510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K202855Orthodontic FacemaskDZB · Traditional Ita.O Italian Orthodontic System S.R.L.06/21/2021SE
K162543Reverse Pull Adjustable FacemaskDZB · Traditional Sawbros Industries Pvt., Ltd.08/28/2017SE
K111169Protraction Face Mask, Reverse Pull Face Mask Model Km-Pvs, Km-Pis, Km-Pvm, Km-Pim…DZB · Traditional Kwang Myung Daicom, Inc.10/03/2011SE
K103019KJ MaskDZB · Traditional Kj Meditech Co., Ltd.06/09/2011SE
K052553Nitom Locking FacebowDZB · Traditional Russell Samuels Orthodontic Design12/22/2005SE
K051751Equa-Pull Safety Release ModuleDZB · Traditional Ortho Technology07/22/2005SE
K041718Keles FacemaskDZB · Traditional Great Lakes Orthodontics, Ltd.10/15/2004SE
K032392Morales Protraction FacemaskDZB · Traditional Ortosim, S.A. DE C.V.10/22/2003SE
K000358Multi Adjustable Face MaskDZB · Traditional Ortho Technology06/09/2000SE
K993224T-Gear, Model TG/400-700DZB · Traditional Dontech Products B.V.02/11/2000SE
K982088Affirm Smart Releasable Force Module and Compliance Science SystemDZB · Traditional Ortho Kinetics Corp.09/04/1998SE
K980436Class III Reverse Pull FacemaskDZB · Traditional Ortho Kinetics Corp.04/27/1998SE
K980245Nitom Locking FacebowDZB · Traditional Ortho Kinetics Corp.04/21/1998SE
K980151Releasable Force ModuleDZB · Traditional Ortho Kinetics Corp.04/06/1998SE
K980195FacebowDZB · Traditional Ortho Kinetics Corp.03/11/1998SE
K961754Safety Release ModuleDZB · Traditional G & H Wire Co.07/10/1996SE
K955528CLP BonnetDZB · Traditional Clp Products02/14/1996SE
K950121France OrthodontieDZB · Traditional France Orthodontie03/08/1995SE
K936151Extraoral HeadgearDZB · Traditional Dentauraum, Inc.08/01/1994SE
K940410New Gear Releasable HeadgearDZB · Traditional Ortho Kinetics Corp.03/10/1994SE
K932761Soft-Wear Headgear and Safety ModulesDZB · Traditional Professional Positioners, Inc.10/07/1993SE
K925240FacebowDZB · Traditional Forestadent Bernhard Forster GmbH06/18/1993SE
K923556Adp FacemaskDZB · Traditional Ormco Corp.12/04/1992SE
K920784Orthodontic Face Bow W/ Inner WireDZB · Traditional Gac Intl., Inc.03/20/1992SE
K912682Orthodontic HeadgearDZB · Traditional K-Tek Orthodontic Products12/09/1991SE
K902646Hood Gear (TM) Breakaway Headgear with Neck StrapDZB · Traditional Ormco Corp.09/06/1990SE
K902645Hood Gear (TM) Breakaway Headgear W/ High PullDZB · Traditional Ormco Corp.09/06/1990SE
K901958Guardian Safe BowDZB · Traditional Lancer Orthodontics, Inc.07/30/1990SE
K862538Sentry Breakway Neck StrapDZB · Traditional Ormco Corp.07/11/1986SE
K861424Adaptable Class III MaskDZB · Traditional Great Lakes Orthodontics, Ltd.05/29/1986SE
K852670A-Company Espree Safety HeadgearDZB · Traditional A Company, Inc.07/31/1985SE
K800748Snap-Way HeadgearDZB · Traditional Northwest Orthodontics, Inc.04/10/1980SE
K790843Snap-WayDZB · Traditional Northwest Orthodontics, Inc.05/31/1979SE
K780747Snap-WayDZB · Traditional Northwest Orthodontics, Inc.05/26/1978SE
K771706Saif-BowDZB · Traditional Northwest Orthodontics, Inc.09/20/1977SE
K771095J Hook HeadgearDZB · Traditional Northwest Orthodontics, Inc.06/24/1977SE