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Device Explorer · FDA GUDID · GMDN 46338

Orthodontic band material

A material typically supplied in the form of rolls, strips, or precut blanks with the attachments in place ready to be configured as orthodontic bands. This is a single-use device.

US‑registered devices69in commercial distribution
Companies5labelers on GUDID
Single‑use94%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda6087%
Rmo, Inc.57%
Osung Mnd Co., Ltd.23%
Darby Dental Supply, Llc11%
Wise Linkers, Llc11%

Top labelers

CompanyDevicesShare
Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda6087%
Rmo, Inc.57%
Osung Mnd Co., Ltd.23%
Darby Dental Supply, Llc11%
Wise Linkers, Llc11%

Company = labeler of record on GUDID. 5 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Darby Dental Supply, LLCRMOArtman InstrumentsOSUNG MNDORTHOMETRIC BANDS

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

FDA product codes

CodeNameDevices
DYOBand, Material, Orthodontic60
DZDTube, Orthodontic5
EBLPin, Retentive And Splinting, And Accessory Instruments2
ECRSETTER, BAND, ORTHODONTIC1
ECIBand, Elastic, Orthodontic1

GMDN & GCC registration

  • GMDN code 46338 · non‑implantable
  • Single‑use 94% · sterile 0% · Rx‑only 96% · 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 band material products are registered in the US?

69 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic band material", from 5 companies. The largest labeler is Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda with 87% of records.

Which FDA product codes apply?

DYO (Band, Material, Orthodontic), DZD (Tube, Orthodontic), EBL (Pin, Retentive And Splinting, And Accessory Instruments), ECR (SETTER, BAND, 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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