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

FDA 510(k) Number Applicant Device Name Decision Date
K852670 A COMPANY, INC. "A"-COMPANY ESPREE SAFETY HEADGEAR 07/31/1985
K955528 CLP PRODUCTS CLP BONNET 02/14/1996
K936151 DENTAURAUM, INC. EXTRAORAL HEADGEAR 08/01/1994
K993224 DONTECH PRODUCTS B.V. T-GEAR, MODEL TG/400-700 02/11/2000
K925240 FORESTADENT BERNHARD FORSTER GMBH FACEBOW 06/18/1993
K950121 FRANCE ORTHODONTIE FRANCE ORTHODONTIE 03/08/1995
K961754 G & H WIRE CO. SAFETY RELEASE MODULE 07/10/1996
K920784 GAC INTL., INC. ORTHODONTIC FACE BOW W/ INNER WIRE 03/20/1992
K861424 GREAT LAKES ORTHODONTICS, LTD. ADAPTABLE CLASS III MASK 05/29/1986
K041718 GREAT LAKES ORTHODONTICS, LTD. KELES FACEMASK 10/15/2004
K912682 K-TEK ORTHODONTIC PRODUCTS ORTHODONTIC HEADGEAR 12/09/1991
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
K901958 LANCER ORTHODONTICS, INC. GUARDIAN SAFE BOW 07/30/1990
K771095 NORTHWEST ORTHODONTICS, INC. "J" HOOK HEADGEAR 06/24/1977
K771706 NORTHWEST ORTHODONTICS, INC. SAIF-BOW 09/20/1977
K780747 NORTHWEST ORTHODONTICS, INC. SNAP-WAY 05/26/1978
K790843 NORTHWEST ORTHODONTICS, INC. SNAP-WAY 05/31/1979
K800748 NORTHWEST ORTHODONTICS, INC. SNAP-WAY HEADGEAR 04/10/1980
K923556 ORMCO CORP. ADP FACEMASK 12/04/1992
K902645 ORMCO CORP. HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL 09/06/1990
K902646 ORMCO CORP. HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP 09/06/1990
K862538 ORMCO CORP. SENTRY BREAKWAY NECK STRAP 07/11/1986
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
K940410 ORTHO KINETICS CORP. NEW GEAR RELEASABLE HEADGEAR 03/10/1994
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
K932761 PROFESSIONAL POSITIONERS, INC. SOFT-WEAR HEADGEAR AND SAFETY MODULES 10/07/1993
K052553 RUSSELL SAMUELS ORTHODONTIC DESIGN NITOM LOCKING FACEBOW 12/22/2005
K162543 SAWBROS INDUSTRIES PVT.LTD. Reverse Pull Adjustable Facemask 08/28/2017


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