Atlas FDA

DZB

36 FDA 510(k) clearances · Product code

82 daysmedian time to decision
240 days90th percentile
36clearances measured

FDA profile

Official device name
Headgear, Extraoral, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5500
Medical specialty
Dental
Flags
Third-party review eligible
Adverse events (MAUDE)
1995: 1 · 1997: 1 · 1998: 3 · 2001: 1 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
Orthodontic Facemask (K202855)Ita.O Italian Orthodontic System S.R.L.2021-06-21
Reverse Pull Adjustable Facemask (K162543)Sawbros Industries Pvt., Ltd.2017-08-28
PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF (K111169)Kwang Myung Daicom, Inc.2011-10-03
KJ MASK (K103019)Kj Meditech Co., Ltd.2011-06-09
NITOM LOCKING FACEBOW (K052553)Russell Samuels Orthodontic Design2005-12-22
EQUA-PULL SAFETY RELEASE MODULE (K051751)Ortho Technology2005-07-22
KELES FACEMASK (K041718)Great Lakes Orthodontics, Ltd.2004-10-15
MORALES PROTRACTION FACEMASK (K032392)Ortosim, S.A. DE C.V.2003-10-22
MULTI ADJUSTABLE FACE MASK (K000358)Ortho Technology2000-06-09
T-GEAR, MODEL TG/400-700 (K993224)Dontech Products B.V.2000-02-11
AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM (K982088)Ortho Kinetics Corp.1998-09-04
CLASS III REVERSE PULL FACEMASK (K980436)Ortho Kinetics Corp.1998-04-27
NITOM LOCKING FACEBOW (K980245)Ortho Kinetics Corp.1998-04-21
RELEASABLE FORCE MODULE (K980151)Ortho Kinetics Corp.1998-04-06
FACEBOW (K980195)Ortho Kinetics Corp.1998-03-11
SAFETY RELEASE MODULE (K961754)G & H Wire Co.1996-07-10
CLP BONNET (K955528)Clp Products1996-02-14
FRANCE ORTHODONTIE (K950121)France Orthodontie1995-03-08
EXTRAORAL HEADGEAR (K936151)Dentauraum, Inc.1994-08-01
NEW GEAR RELEASABLE HEADGEAR (K940410)Ortho Kinetics Corp.1994-03-10
SOFT-WEAR HEADGEAR AND SAFETY MODULES (K932761)Professional Positioners, Inc.1993-10-07
FACEBOW (K925240)Forestadent Bernhard Forster GmbH1993-06-18
ADP FACEMASK (K923556)Ormco Corp.1992-12-04
ORTHODONTIC FACE BOW W/ INNER WIRE (K920784)Gac Intl., Inc.1992-03-20
ORTHODONTIC HEADGEAR (K912682)K-Tek Orthodontic Products1991-12-09
HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP (K902646)Ormco Corp.1990-09-06
HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL (K902645)Ormco Corp.1990-09-06
GUARDIAN SAFE BOW (K901958)Lancer Orthodontics, Inc.1990-07-30
SENTRY BREAKWAY NECK STRAP (K862538)Ormco Corp.1986-07-11
ADAPTABLE CLASS III MASK (K861424)Great Lakes Orthodontics, Ltd.1986-05-29
A-COMPANY ESPREE SAFETY HEADGEAR (K852670)A Company, Inc.1985-07-31
SNAP-WAY HEADGEAR (K800748)Northwest Orthodontics, Inc.1980-04-10
SNAP-WAY (K790843)Northwest Orthodontics, Inc.1979-05-31
SNAP-WAY (K780747)Northwest Orthodontics, Inc.1978-05-26
SAIF-BOW (K771706)Northwest Orthodontics, Inc.1977-09-20
J HOOK HEADGEAR (K771095)Northwest Orthodontics, Inc.1977-06-24

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