Consulting Wallah › Device Explorer › Other devices › Orthodontic face bow
Device Explorer · FDA GUDID · GMDN 40468

Orthodontic face bow

A dental device used in conjunction with extraoral traction anchored on the back of the head or neck, as a long metal bow that inserts intraorally into an orthodontic appliance. Generally used to move teeth or bones posteriorly or prevent their forward movemen

US‑registered devices305in commercial distribution
Companies11labelers on GUDID
Single‑use91%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Leone Spa8327%
Ormco Corporation7826%
G & H Wire Company, Inc.7123%
Henry Schein, Inc.258%
Ortho Organizers, Inc.207%
Ortho Technology, Inc.72%
Forestadent Bernhard Förster Gmbh62%
Rmo, Inc.62%

Top labelers

CompanyDevicesShare
Leone Spa8327%
Ormco Corporation7826%
G & H Wire Company, Inc.7123%
Henry Schein, Inc.258%
Ortho Organizers, Inc.207%
Ortho Technology, Inc.72%
Forestadent Bernhard Förster Gmbh62%
Rmo, Inc.62%
Dental Morelli Ltda62%
Ortho Arch Company Inc21%
Hangzhou Dtc Medical Apparatus Co., Ltd.10%

Company = labeler of record on GUDID. 11 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DTCn.A.FacebowSRX FacebowBrite-GearSR FacebowPenta-FormORTHO ARCHOrtho ArchHenry ScheinFull Form Extraoral FacebowMaselOrtho OrganizersNAG&H STANDARD FACEBOWODP FACEBOW

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, orthodontic190
DZBHeadgear, Extraoral, Orthodontic106
KCRFACEBOW28
EIGRetractor, All Types2
ECNClamp, Wire, Orthodontic1

GMDN & GCC registration

  • GMDN code 40468 · non‑implantable
  • Single‑use 91% · sterile 0% · Rx‑only 100% · 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 face bow products are registered in the US?

305 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic face bow", from 11 companies. The largest labeler is Leone Spa with 27% of records.

Which FDA product codes apply?

DZB (Headgear, extraoral, orthodontic), DZB (Headgear, Extraoral, Orthodontic), KCR (FACEBOW), EIG (Retractor, All Types)

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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