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Data / Medical devices / Headgear, Extraoral, Orthodontic

Headgear, Extraoral, Orthodontic (DZB): 17 FDA-registered makers in 7 countries

17 establishments in 7 countries are registered with the FDA to make Headgear, Extraoral, Orthodontic (product code DZB, Class 2, 21 CFR 872.5500). 12 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 36 510(k) clearances under this code, the latest on June 21, 2021, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
DZB
Device class
2
Regulation
872.5500
Medical specialty
Dental

Makers by country

CountryMakers
United States8
South Korea2
Italy2
Mexico2
Germany1
India1
Switzerland1

Makers of Headgear, Extraoral, Orthodontic

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Ortho Kinetics Corp.Vista, CA, United StatesContract manufacturer, Manufacturer5April 27, 1998000api.fda.gov
Ortho Organizers, Inc.Savannah, GA, United StatesManufacturer, Repackager or relabeler, Specification developer5June 9, 2000000api.fda.gov
Ormco CorporationPomona, CA, United StatesComplaint file establishment, Specification developer5March 11, 1998000api.fda.gov
Ormco CorporationBrea, CA, United StatesComplaint file establishment, Specification developer5March 11, 1998000api.fda.gov
G & H Wire CompanyFranklin, IN, United StatesManufacturer, Repackager or relabeler2October 3, 2011000api.fda.gov
Dentaurum GmbH & Co. KGISPRINGEN Baden-Wurttemberg, GermanyManufacturer1August 1, 1994000api.fda.gov
Great Lakes Dental Technologies, Ltd.Tonawanda, NY, United StatesManufacturer1May 29, 1986000api.fda.gov
KJ Meditech Co., Ltd.Gwangju, South KoreaManufacturer1June 9, 2011000api.fda.gov
Kwang Myung Daicom Ltd.Seoul, South KoreaManufacturer1October 3, 2011000api.fda.gov
Orthodontic Manufacturer Sia SRLROCCA D EVANDRO Caserta, ItalyManufacturer1July 10, 1996000api.fda.gov
Ortosim, S.A. De C.V.TLALNEPANTLA Mexico, MexicoContract manufacturer, Manufacturer1October 22, 2003000api.fda.gov
Sawbros Industries Pvt LtdNOIDA Uttar Pradesh, IndiaManufacturer1August 28, 2017000api.fda.gov
Gunmed Technik AGWELSCHENROHR Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Leone SPASesto Fiorentino Firenze, ItalyManufacturer0000api.fda.gov
SDS de Mexico S. de R.L. de C.V.MEXICALI, B.C. C.P. Baja California, MexicoContract manufacturer0000api.fda.gov
Solventum Orthodontics CorporationMonrovia, CA, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Taurus Engineering And Manufacturing, Inc.Saint Paul, MN, United StatesContract manufacturer0000api.fda.gov

Updated June 21, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.