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Device Explorer · FDA GUDID · GMDN 45251

Orthodontic appliance relief material

A device used to cover the offending sharp edges of an orthodontic appliance being worn by the user in order to provide relief from the discomforts that this can cause. It can be presented as a sheet, strip, or rod and is typically made of a mouldable wax or s

US‑registered devices144in commercial distribution
Companies24labelers on GUDID
Single‑use90%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Ortho Organizers, Inc.4229%
Ortho Technology, Inc.1510%
G & H Wire Company, Inc.128%
Jmu Dental, Inc118%
Ortho Pro Dent Llc107%
Henry Schein, Inc.75%
Young Innovations, Inc.64%
Gc Orthodontics America Inc.64%

Top labelers

CompanyDevicesShare
Ortho Organizers, Inc.4229%
Ortho Technology, Inc.1510%
G & H Wire Company, Inc.128%
Jmu Dental, Inc118%
Ortho Pro Dent Llc107%
Henry Schein, Inc.75%
Young Innovations, Inc.64%
Gc Orthodontics America Inc.64%
Dentos Inc.64%
Dentaurum Gmbh & Co.Kg53%
Leone Spa53%
3M Unitek Corporation32%

Company = labeler of record on GUDID. 24 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

InhwRiorDenar Bite WaxGishy GooYoung SpecialtiesPlak SmackerThe Orthodontic StoreReliaWaxOrVanceJMU3D DentalOrtho Pro3M™3M™ Wax-Pak™ACEHenry ScheinMor-Tight

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

FDA product codes

CodeNameDevices
EGDWAX, DENTAL, INTRAORAL83
EGDWax, Dental, Intraoral38
ECIBAND, ELASTIC, ORTHODONTIC20
ECIBand, Elastic, Orthodontic4
DZNINSTRUMENTS, DENTAL HAND3
EIGRETRACTOR, ALL TYPES2

GMDN & GCC registration

  • GMDN code 45251 · non‑implantable
  • Single‑use 90% · sterile 0% · Rx‑only 76% · OTC 3%
  • 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 appliance relief material products are registered in the US?

144 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic appliance relief material", from 24 companies. The largest labeler is Ortho Organizers, Inc. with 29% of records.

Which FDA product codes apply?

EGD (WAX, DENTAL, INTRAORAL), EGD (Wax, Dental, Intraoral), ECI (BAND, ELASTIC, ORTHODONTIC), ECI (Band, Elastic, Orthodontic)

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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