Device Explorer · FDA GUDID · GMDN 31759

Orthodontic tube

A device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the treatment (single-u

US‑registered devices11,236in commercial distribution
Companies35labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription94%Rx‑only share
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Share of device records

Forestadent Bernhard Förster Gmbh2,34521%
American Orthodontics Corporation2,14019%
3M Unitek Corporation1,27211%
G & H Wire Company, Inc.1,07210%
Ortho Organizers, Inc.9058%
Leone Spa7236%
Ormco Corporation5965%
Rmo, Inc.5145%

Top labelers

CompanyDevicesShare
Forestadent Bernhard Förster Gmbh2,34521%
American Orthodontics Corporation2,14019%
3M Unitek Corporation1,27211%
G & H Wire Company, Inc.1,07210%
Ortho Organizers, Inc.9058%
Leone Spa7236%
Ormco Corporation5965%
Rmo, Inc.5145%
World Class Technology Corporation2222%
Tp Orthodontics Inc1852%
Ortho Technology, Inc.1842%
Gni Co.,Ltd1551%

Company = labeler of record on GUDID. 35 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

meitedentalDTCTonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,LRTonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,LLTonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,URTonia Tube,1st M.,.022 Roth,Bond,Sgl,N-Cov,ULMETAL SELF- LIGATING Tube 022 MBT LR6METAL SELF- LIGATING Tube 022 MBT LL606Y Metal Self-Ligating Tube -10 UR/LL05Y Metal Self-Ligating Tube -10 UL/LR04Y Metal Self-Ligating Tube -20 UR/LL03Y Metal Self-Ligating Tube -20 UL/LR02Y Metal Self-Ligating Tube -30 UR/LL01Y Metal Self-Ligating Tube -30 UL/LRMIRABAYMico One Orthodontic Tube

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

FDA product codes

CodeNameDevices
DZDTUBE, ORTHODONTIC8,515
DZDTube, Orthodontic3,360
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN661
ECNCLAMP, WIRE, ORTHODONTIC30
EJFBracket, Metal, Orthodontic14
NDPACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS8

GMDN & GCC registration

  • GMDN code 31759 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 94% · 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.

No closely related category with 50+ devices.

How many orthodontic tube products are registered in the US?

11,236 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic tube", from 35 companies. The largest labeler is Forestadent Bernhard Förster Gmbh with 21% of records.

Which FDA product codes apply?

DZD (TUBE, ORTHODONTIC), DZD (Tube, Orthodontic), DYH (ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN), ECN (CLAMP, WIRE, 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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