Dental Device Guide
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Therapeutic devices · 21 CFR 872 Subpart F

Orthodontic Extraoral Headgear

FDA device type “Headgear, Extraoral, Orthodontic”.

FDA codeDZBClass221 CFR872.5500Pathway510(k)CategoryRetainers, expanders & headgear
Companies listing it
2415 makers
Brands and models
58
510(k) clearances
360 in five years
FDA name
Headgear, Extraoral, Orthodontic
1977: 21978: 11979: 11980: 11985: 11986: 21990: 31991: 11992: 21993: 21994: 21995: 11996: 21998: 52000: 22003: 12004: 12005: 22011: 22017: 12021: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list DZB

24 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Sybron Dental SpecialtiesUnited StatesMaker—2032026
KJ Meditech Co., Ltd.South KoreaMakerKJ MASK132022
Ortho Organizers, Inc.United StatesMakerCervical Neck Pads · ClassOne Facemask · ClassOne Safety Release Modules · Extraoral Facebows · +682025
Leone S.P.A.ItalyMakerOrthodontic headgear, facemask/bow42025
Ortho Kinetics Corp.United StatesMakerAD Protraction Facemask · Facebow · Locking Facebow · NewGear Releasable Headgear · +271998
G&H Wire CompanyUnited StatesMakerN/A22008
Sawbros Industries Pvt., Ltd.IndiaMakerReverse Pull Adjustable Facemask12017
Fernando Morales GarfiasMexicoMakerAD Protraction Facemask · Asian Profile AD Protraction Facemask · MORALES PROTRACTION FACEMASK12003
Kwang Myung Daicom, Inc.South KoreaMakerHeadgear12011
Dentaurum GmbH & Co. KGGermanyMakerFace mask · High-pull headgear · Reverse-pull headgear · Universal-pull headgear · +1——
Great Lakes Dental Technologies, Ltd.United StatesMakerAdaptable Class III Mask · Great Lakes Face Cribs · Nola Head gear——
Solventum US LLCUnited StatesMakerFriction-Stop Adjustage Facebow · Level Anchorage Facebow · NWO Headgear · NWO Snap-way · +2——
Orthodontic Manufacturer SIA SRLItalyMakerSIA ORTHODONTIC MANUFACTURER——
Gunmed Technik AGSwitzerlandMakerHOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP——
Taurus Engineering and Manufacturing, Inc.United StatesMakerMULTI ADJUSTABLE FACE MASK——
American OrthodonticsUnited StatesContract manufacturerEAGLEWEAR; · Protraction Face Mask442026
Young Innovations IncUnited StatesContract manufacturerAmerican Flag Class III Adjustable Facemask · Flames Class III Adjustable Facemask · Hawaiian Print Class III Adjustable Facemask · Leopard Print Class III Adjustable Facemask · +4232025
Rmo, Inc.United StatesManufacturerOrthopedic Face Mask · Spring Gear/Safety Headgear; Facebow Penta-form;11990
Five Star Orthodontic Laboratory & Supply, Inc.United StatesContract manufacturerFace mask · Multi-Adjustable Face Mask · Pedo reverse pull facemask——
Patterson Companies, Inc.United StatesForeign exporter———
International Orthodontics Services. PCUnited StatesRepacker / relabelerFacebow Universal/ Short/ Medium/ Long——
Csy International LLCUnited StatesRepacker / relabelerJ&J ORTHODONTICS——
White Oak Orthodontic ProductsUnited StatesRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———

510(k) clearances

Decided510(k)DeviceApplicant
21 Jun 2021K202855Orthodontic FacemaskIta.O Italian Orthodontic System S.R.L.
28 Aug 2017K162543Reverse Pull Adjustable FacemaskSawbros Industries Pvt., Ltd.
3 Oct 2011K111169PROTRACTION 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.
9 Jun 2011K103019KJ MASKKJ Meditech Co., Ltd.
22 Dec 2005K052553NITOM LOCKING FACEBOWRussell Samuels Orthodontic Design
22 Jul 2005K051751EQUA-PULL SAFETY RELEASE MODULEOrtho Technology, Inc.
15 Oct 2004K041718KELES FACEMASKGreat Lakes Orthodontics, Ltd.
22 Oct 2003K032392MORALES PROTRACTION FACEMASKFernando Morales Garfias
9 Jun 2000K000358MULTI ADJUSTABLE FACE MASKOrtho Technology, Inc.
11 Feb 2000K993224T-GEAR, MODEL TG/400-700Dontech Products B.V.
4 Sep 1998K982088AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEMOrtho Kinetics Corp.
27 Apr 1998K980436CLASS III REVERSE PULL FACEMASKOrtho Kinetics Corp.
21 Apr 1998K980245NITOM LOCKING FACEBOWOrtho Kinetics Corp.
6 Apr 1998K980151RELEASABLE FORCE MODULEOrtho Kinetics Corp.
11 Mar 1998K980195FACEBOWOrtho Kinetics Corp.
10 Jul 1996K961754SAFETY RELEASE MODULEG&H Wire Company
14 Feb 1996K955528CLP BONNETClp Products
8 Mar 1995K950121FRANCE ORTHODONTIEFrance Orthodontie
1 Aug 1994K936151EXTRAORAL HEADGEARDentauraum, Inc.
10 Mar 1994K940410NEW GEAR RELEASABLE HEADGEAROrtho Kinetics Corp.
7 Oct 1993K932761SOFT-WEAR HEADGEAR AND SAFETY MODULESProfessional Positioners, Inc.
18 Jun 1993K925240FACEBOWForestadent Bernhard Forster GmbH
4 Dec 1992K923556ADP FACEMASKSybron Dental Specialties
20 Mar 1992K920784ORTHODONTIC FACE BOW W/ INNER WIREGac Intl., Inc.
9 Dec 1991K912682ORTHODONTIC HEADGEARK-Tek Orthodontic Products
6 Sep 1990K902646HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAPSybron Dental Specialties
6 Sep 1990K902645HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULLSybron Dental Specialties
30 Jul 1990K901958GUARDIAN SAFE BOWLancer Orthodontics, Inc.
11 Jul 1986K862538SENTRY BREAKWAY NECK STRAPSybron Dental Specialties
29 May 1986K861424ADAPTABLE CLASS III MASKGreat Lakes Orthodontics, Ltd.
31 Jul 1985K852670A-COMPANY ESPREE SAFETY HEADGEARA Company, Inc.
10 Apr 1980K800748SNAP-WAY HEADGEARNorthwest Orthodontics, Inc.
31 May 1979K790843SNAP-WAYNorthwest Orthodontics, Inc.
26 May 1978K780747SNAP-WAYNorthwest Orthodontics, Inc.
20 Sep 1977K771706SAIF-BOWNorthwest Orthodontics, Inc.
24 Jun 1977K771095J HOOK HEADGEARNorthwest Orthodontics, Inc.

Official records: FDA product classification for DZB · 21 CFR 872.5500.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026