Headgear, Extraoral, Orthodontic
Dental · 21 CFR 872.5500
Recent MDR events
17 adverse event reports on file
- DENTAL IMPLANTMay 4, 2026MalfunctionUnkMW5187656
- ORTHODONTIC FACEMASKJun 22, 2021Malfunction3015332216-2021-00001
- A.D. PROTRACTION FASKMASKDec 17, 2018InjuryOrmco Corporation2016150-2018-00061
- FACEBOWNov 6, 2017InjuryOrmco Corporation2016150-2017-00005
- HIGH PULL HEADGEARApr 11, 2014InjuryOrmco Corporation2016150-2014-00026
- PROTRACTION FACEMASKFeb 26, 2013InjuryGac International2418500-2013-00001
- ADAPTABLE CLASS III MASKAug 30, 2011InjuryGreat Lakes Orthodontics Ltd1316408-2011-00001
- ADAPTABLE CLASS III MASKJul 31, 2011InjuryGreat Lakes Orthodontics, Ltd.MW5021564
- FACE BOWMar 14, 2007InjuryAmerican Orthodontics2126683-2005-00002
- FACE BOWNov 8, 2005American Orthodontics2126683-2005-00001
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
59 firms currently registered for this product code
Rmo
Franklin, IN, US
Csy International Llc
Rancho Cucamonga, CA, US
Leone Spa
Sesto Fiorentino Firenze, IT
Kwang Myung Daicom Ltd.
SEOUL, KR
Dentaurum Gmbh & Co. Kg
ISPRINGEN Baden-Wurttemberg, DE
Five Star Orthodontic Laboratory & Supply, Inc.
Denton, TX, US
Sds De Mexico S. De R.l. De C.v.
MEXICALI, B.C. C.P. Baja California, MX
Ortosim, S.a. De C.v.
TLALNEPANTLA Mexico, MX
Ortho Kinetics Corp.
VISTA, CA, US
White Oak Orthodontic Products
Mount Joy, PA, US
Ormco Corporation
Pomona, CA, US
Gunmed Technik Ag
WELSCHENROHR Solothurn, CH
American Orthodontics
SHEBOYGAN, WI, US
Great Lakes Dental Technologies, Ltd.
TONAWANDA, NY, US
Mainline Medical Dental Supply
North York Ontario, CA
Taurus Engineering And Manufacturing, Inc.
Saint Paul, MN, US
Kj Meditech Co., Ltd.
Gwangju, KR
G & H Wire Company
Franklin, IN, US
Ormco Corporation
Brea, CA, US
510(k) clearances
36 clearances for this product code
- Ita.O Italian Orthodontic System S.R.L.Jun 21, 2021
K202855 · Orthodontic Facemask
- Sawbros Industries Pvt., Ltd.Aug 28, 2017
K162543 · Reverse Pull Adjustable Facemask
- Kwang Myung Daicom, Inc.Oct 3, 2011
K111169 · PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF
- Kj Meditech Co., Ltd.Jun 9, 2011
K103019 · KJ MASK
- Russell Samuels Orthodontic DesignDec 22, 2005
K052553 · NITOM LOCKING FACEBOW
- Ortho TechnologyJul 22, 2005
K051751 · EQUA-PULL SAFETY RELEASE MODULE
- Great Lakes Orthodontics, Ltd.Oct 15, 2004
K041718 · KELES FACEMASK
- Ortosim, S.A. DE C.V.Oct 22, 2003
K032392 · MORALES PROTRACTION FACEMASK