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Device Explorer · FDA GUDID · GMDN 31757

Orthodontic extraoral headgear

A dental device used in conjunction with orthodontic appliances to exert pressure on the teeth or the jaws from outside the mouth. An orthodontic headgear will typically have a strap that wraps around the patient's neck or head and an inner bow portion that is

US‑registered devices638in commercial distribution
Companies23labelers on GUDID
Single‑use50%of device records
Sterile0%labelled sterile
Prescription99%Rx‑only share
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Share of device records

3M Unitek Corporation9014%
Ortho Organizers, Inc.8714%
Orthoquest, Inc.6911%
Lancer Orthodontics, Inc.6510%
G & H Wire Company, Inc.6410%
Great Lakes Dental Technologies, Ltd.416%
Leone Spa416%
Ortho Technology, Inc.386%

Top labelers

CompanyDevicesShare
3M Unitek Corporation9014%
Ortho Organizers, Inc.8714%
Orthoquest, Inc.6911%
Lancer Orthodontics, Inc.6510%
G & H Wire Company, Inc.6410%
Great Lakes Dental Technologies, Ltd.416%
Leone Spa416%
Ortho Technology, Inc.386%
Ormco Corporation264%
Flexmedics223%
Rmo, Inc.173%
Forestadent Bernhard Förster Gmbh132%

Company = labeler of record on GUDID. 23 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Reverse Pull Headgear(Face Mask), Middle, GreenReverse Pull Headgear(Face Mask), Middle, PurpleReverse Pull Headgear(Face Mask), Middle, OrangeReverse Pull Headgear(Face Mask), Middle, YellowReverse Pull Headgear(Face Mask), Middle, BlueReverse Pull Headgear(Face Mask), Middle, RedN.A.BrightGear HeadgearA.D. ProtractionAD Protraction FacemaskC-Type Release ModuleRelease ModuleSentry HeadgearRMOMorales Plus Protraction Face MaskMorales Mini Protraction Face Mask

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DZBHeadgear, extraoral, orthodontic335
DZBHeadgear, Extraoral, Orthodontic332
KCRFACEBOW46
KCRFacebow6
DZCWIRE, ORTHODONTIC1
DZMNeedle, Dental1

GMDN & GCC registration

  • GMDN code 31757 · non‑implantable
  • Single‑use 50% · sterile 0% · Rx‑only 99% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

No structured size data on the register.

Use these as the dimensions to specify in a tender line.

How many orthodontic extraoral headgear products are registered in the US?

638 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic extraoral headgear", from 23 companies. The largest labeler is 3M Unitek Corporation with 14% of records.

Which FDA product codes apply?

DZB (Headgear, extraoral, orthodontic), DZB (Headgear, Extraoral, Orthodontic), KCR (FACEBOW), KCR (Facebow)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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