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Device Explorer · FDA GUDID · GMDN 65804

Orthodontic rod-based aligner

An orthodontic device which includes a rod(s) intended to be bonded to teeth to correct malocclusions (e.g., overbites); it is commonly known as Herbst appliance. The rod, also referred to as a piston or tube, is typically positioned with a metal band and/or b

US‑registered devices268in commercial distribution
Companies6labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

American Orthodontics Corporation20275%
Tp Orthodontics Inc2911%
Specialty Appliances, Llc2810%
Five Star Orthodontic Laboratory & Supply Inc52%
Allesee Aoa-Pro31%
Ormco Corporation10%

Top labelers

CompanyDevicesShare
American Orthodontics Corporation20275%
Tp Orthodontics Inc2911%
Specialty Appliances, Llc2810%
Five Star Orthodontic Laboratory & Supply Inc52%
Allesee Aoa-Pro31%
Ormco Corporation10%

Company = labeler of record on GUDID. 6 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tandum Traction ApplianceM.A.R.A.MARAHerbst Bite JumperMara ApplianceCantilever HerbstHerbst Mini Telescoping ArmHerbst Mini TelescopingHerbst ApplianceHTH / APPLECORE SCREWFlip-Lock® Arm-LeftFlip-Lock® Arm-RightFlip-Lock® Rod-LowerHTH®-Left 24mmHTH®-Right 24mmHTH®-Left 21mm

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

FDA product codes

CodeNameDevices
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC298
DYJRetainer, Screw Expansion, Orthodontic29
ECOSPRING, ORTHODONTIC12
ECNClamp, Wire, Orthodontic10
DZNInstruments, Dental Hand6
DZCWire, Orthodontic5

GMDN & GCC registration

  • GMDN code 65804 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 89% · 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 rod-based aligner products are registered in the US?

268 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic rod-based aligner", from 6 companies. The largest labeler is American Orthodontics Corporation with 75% of records.

Which FDA product codes apply?

DYJ (RETAINER, SCREW EXPANSION, ORTHODONTIC), DYJ (Retainer, Screw Expansion, Orthodontic), ECO (SPRING, ORTHODONTIC), 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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