Product Code: DZB


Products Classified as DZB

1098Headgear, Extraoral, OrthodonticExtraoral Orthodontic Headgear.

Total Product Life Cycle (TPLC) Devices

1098Headgear, Extraoral, OrthodonticExtraoral Orthodontic Headgear.

FDA Consensus Standards

Headgear, Extraoral, Orthodontic [34709]21 CFR §872.5500 🔎
Headgear, Extraoral, Orthodontic [32013]21 CFR §872.5500 🔎

Pre-market Notifications for DZB

K202855Orthodontic FacemaskITA.O Italian Orthodontic System S.r.l.
K162543Reverse Pull Adjustable FacemaskSAWBROS INDUSTRIES PVT.LTD.
K111169PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMFKWANG MYUNG DAICOM INC
K103019KJ MASKKJ MEDITECH CO., LTD
K052553NITOM LOCKING FACEBOWRUSSELL SAMUELS ORTHODONTIC DESIGN
K041718KELES FACEMASKGREAT LAKES ORTHODONTICS, LTD.
K032392MORALES PROTRACTION FACEMASKORTOSIM, S.A. DE C.V.
K000358MULTI ADJUSTABLE FACE MASKORTHO TECHNOLOGY
K993224T-GEAR, MODEL TG/400-700DONTECH PRODUCTS B.V.
K982088AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEMORTHO KINETICS CORP.
K980436CLASS III REVERSE PULL FACEMASKORTHO KINETICS CORP.
K980245NITOM LOCKING FACEBOWORTHO KINETICS CORP.
K980195FACEBOWORTHO KINETICS CORP.
K980151RELEASABLE FORCE MODULEORTHO KINETICS CORP.
K961754SAFETY RELEASE MODULEG & H WIRE CO.

Global Unique Device Identification Database

00304040027073Headgear, extraoral, orthodontic
00304040027066Headgear, extraoral, orthodontic
00304040027059Headgear, extraoral, orthodontic
00304040027042Headgear, extraoral, orthodontic
00304040027035Headgear, extraoral, orthodontic
00304040027028Headgear, extraoral, orthodontic
00304040027011Headgear, extraoral, orthodontic
00304040027004Headgear, extraoral, orthodontic
00304040018651Headgear, extraoral, orthodontic
00304040018644Headgear, extraoral, orthodontic
00304040018637Headgear, extraoral, orthodontic
00304040018620Headgear, extraoral, orthodontic
00304040018613Headgear, extraoral, orthodontic
00304040018606Headgear, extraoral, orthodontic
00304040018590Headgear, extraoral, orthodontic

Maude Adverse Events

A.D. PROTRACTION FACEMASKORMCO CORPORATION2018-12-17
FACEBOWORMCO CORPORATION2017-11-06
HIGH PULL HEADGEARORMCO CORPORATION2014-04-11
PROTRACTION FACEMASKGAC INTERNATIONAL2013-02-26
ADAPTABLE CLASS III MASKGREAT LAKES ORTHODONTICS LTD2011-08-30
ADAPTABLE CLASS III MASKGREAT LAKES ORTHODONTICS, LTD.2011-07-31
FACE BOWAMERICAN ORTHODONTICS2007-03-14
FACE BOWAMERICAN ORTHODONTICS2005-11-08
UNKORTHODONTIC HEADGEARUNK2002-08-26
FRICTION - STOP ADJUSTABLE FACEBOW3M UNITEK2001-10-31
ORMCO C-TYPE RELEASE MODULESORMCO CORP.1998-03-17
ORMCO C-TYPE RELEASE MODULESORMCO CORP.1998-03-17
ORMCO C-TYPE RELEASE MODULESORMCO CORP.1998-03-17
NONE"A" COMPANY ORTHODONTICS1997-07-23
HIGH-PULL HEADCAPHOOD-GEAR PACIFIC, INC.1995-04-25
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