Product Code: DZB FDA class 2 21 CFR 872.5500

Headgear, Extraoral, Orthodontic

Dental

The Extraoral Orthodontic Headgear is a dental device worn partially outside the mouth that applies forces to the teeth, jaw, or skull through intraoral attachments to correct skeletal discrepancies or to restrain jaw growth during orthodontic treatment. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZB and the applicable regulation is 21 CFR 872.5500, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DZB
Device Class: FDA class 2
Regulation Number: 872.5500
Medical Specialty: Dental
Review Panel: DE
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 36 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K202855	Orthodontic Facemask	Jun 21, 2021	Substantially Equivalent	Ita.O Italian Orthodontic System S.R.L.
K162543	Reverse Pull Adjustable Facemask	Aug 28, 2017	Substantially Equivalent	Sawbros Industries Pvt., Ltd.
K111169	PROTRACTION FACE MASK, REVERSE PULL FACE MASK MODEL KM-PVS, KM-PIS, KM-PVM, KM-PIM, MODEL KM-FMS, KM-FML, KM-FMF	Oct 03, 2011	Substantially Equivalent	Kwang Myung Daicom, Inc.
K103019	KJ MASK	Jun 09, 2011	Substantially Equivalent	Kj Meditech Co., Ltd.
K052553	NITOM LOCKING FACEBOW	Dec 22, 2005	Substantially Equivalent	Russell Samuels Orthodontic Design
K051751	EQUA-PULL SAFETY RELEASE MODULE	Jul 22, 2005	Substantially Equivalent	Ortho Technology
K041718	KELES FACEMASK	Oct 15, 2004	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K032392	MORALES PROTRACTION FACEMASK	Oct 22, 2003	Substantially Equivalent	Ortosim, S.A. DE C.V.
K000358	MULTI ADJUSTABLE FACE MASK	Jun 09, 2000	Substantially Equivalent	Ortho Technology
K993224	T-GEAR, MODEL TG/400-700	Feb 11, 2000	Substantially Equivalent	Dontech Products B.V.
K982088	AFFIRM SMART RELEASABLE FORCE MODULE AND COMPLIANCE SCIENCE SYSTEM	Sep 04, 1998	Substantially Equivalent	Ortho Kinetics Corp.
K980436	CLASS III REVERSE PULL FACEMASK	Apr 27, 1998	Substantially Equivalent	Ortho Kinetics Corp.
K980245	NITOM LOCKING FACEBOW	Apr 21, 1998	Substantially Equivalent	Ortho Kinetics Corp.
K980151	RELEASABLE FORCE MODULE	Apr 06, 1998	Substantially Equivalent	Ortho Kinetics Corp.
K980195	FACEBOW	Mar 11, 1998	Substantially Equivalent	Ortho Kinetics Corp.
K961754	SAFETY RELEASE MODULE	Jul 10, 1996	Substantially Equivalent	G & H Wire Co.
K955528	CLP BONNET	Feb 14, 1996	Substantially Equivalent	Clp Products
K950121	FRANCE ORTHODONTIE	Mar 08, 1995	Substantially Equivalent	France Orthodontie
K936151	EXTRAORAL HEADGEAR	Aug 01, 1994	Substantially Equivalent	Dentauraum, Inc.
K940410	NEW GEAR RELEASABLE HEADGEAR	Mar 10, 1994	Substantially Equivalent	Ortho Kinetics Corp.
K932761	SOFT-WEAR HEADGEAR AND SAFETY MODULES	Oct 07, 1993	Substantially Equivalent	Professional Positioners, Inc.
K925240	FACEBOW	Jun 18, 1993	Substantially Equivalent	Forestadent Bernhard Forster GmbH
K923556	ADP FACEMASK	Dec 04, 1992	Substantially Equivalent	Ormco Corp.
K920784	ORTHODONTIC FACE BOW W/ INNER WIRE	Mar 20, 1992	Substantially Equivalent	Gac Intl., Inc.
K912682	ORTHODONTIC HEADGEAR	Dec 09, 1991	Substantially Equivalent	K-Tek Orthodontic Products
K902646	HOOD GEAR (TM) BREAKAWAY HEADGEAR WITH NECK STRAP	Sep 06, 1990	Substantially Equivalent	Ormco Corp.
K902645	HOOD GEAR (TM) BREAKAWAY HEADGEAR W/ HIGH PULL	Sep 06, 1990	Substantially Equivalent	Ormco Corp.
K901958	GUARDIAN SAFE BOW	Jul 30, 1990	Substantially Equivalent	Lancer Orthodontics, Inc.
K862538	SENTRY BREAKWAY NECK STRAP	Jul 11, 1986	Substantially Equivalent	Ormco Corp.
K861424	ADAPTABLE CLASS III MASK	May 29, 1986	Substantially Equivalent	Great Lakes Orthodontics, Ltd.
K852670	A-COMPANY ESPREE SAFETY HEADGEAR	Jul 31, 1985	Substantially Equivalent	A Company, Inc.
K800748	SNAP-WAY HEADGEAR	Apr 10, 1980	Substantially Equivalent	Northwest Orthodontics, Inc.
K790843	SNAP-WAY	May 31, 1979	Substantially Equivalent	Northwest Orthodontics, Inc.
K780747	SNAP-WAY	May 26, 1978	Substantially Equivalent	Northwest Orthodontics, Inc.
K771706	SAIF-BOW	Sep 20, 1977	Substantially Equivalent	Northwest Orthodontics, Inc.
K771095	J HOOK HEADGEAR	Jun 24, 1977	Substantially Equivalent	Northwest Orthodontics, Inc.