FDA 510(k) Applications for Medical Device Product Code: DZB (Headgear, Extraoral, Orthodontic)

FDA 510(k) Applications for Medical Device Product Code "DZB"
(Headgear, Extraoral, Orthodontic)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K955528	CLP PRODUCTS	CLP BONNET	02/14/1996
K993224	DONTECH PRODUCTS B.V.	T-GEAR, MODEL TG/400-700	02/11/2000
K961754	G & H WIRE CO.	SAFETY RELEASE MODULE	07/10/1996
K041718	GREAT LAKES ORTHODONTICS, LTD.	KELES FACEMASK	10/15/2004
K202855	ITA.O Italian Orthodontic System S.r.l.	Orthodontic Facemask	06/21/2021
K103019	KJ MEDITECH CO., LTD	KJ MASK	06/09/2011
K111169	KWANG MYUNG DAICOM INC	PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF	10/03/2011
K982088	ORTHO KINETICS CORP.	AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM	09/04/1998
K980436	ORTHO KINETICS CORP.	CLASS III REVERSE PULL FACEMASK	04/27/1998
K980195	ORTHO KINETICS CORP.	FACEBOW	03/11/1998
K980245	ORTHO KINETICS CORP.	NITOM LOCKING FACEBOW	04/21/1998
K980151	ORTHO KINETICS CORP.	RELEASABLE FORCE MODULE	04/06/1998
K051751	ORTHO TECHNOLOGY	EQUA-PULL SAFETY RELEASE MODULE	07/22/2005
K000358	ORTHO TECHNOLOGY	MULTI ADJUSTABLE FACE MASK	06/09/2000
K032392	ORTOSIM, S.A. DE C.V.	MORALES PROTRACTION FACEMASK	10/22/2003
K052553	RUSSELL SAMUELS ORTHODONTIC DESIGN	NITOM LOCKING FACEBOW	12/22/2005
K162543	SAWBROS INDUSTRIES PVT.LTD.	Reverse Pull Adjustable Facemask	08/28/2017