Consulting Wallah › Device Explorer › Other devices › Orthodontic palate expander/teeth aligner, bonded
Device Explorer · FDA GUDID · GMDN 64769

Orthodontic palate expander/teeth aligner, bonded

An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism, positioned in the palate cavit

US‑registered devices202in commercial distribution
Companies9labelers on GUDID
Single‑use93%of device records
Sterile0%labelled sterile
Prescription90%Rx‑only share
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Share of device records

Five Star Orthodontic Laboratory & Supply Inc7437%
American Orthodontics Corporation5829%
Dentaurum Gmbh & Co.Kg2613%
Tp Orthodontics Inc136%
Dental Morelli Ltda136%
Allesee Aoa-Pro84%
Young Innovations, Inc.63%
Mk Meditech Inc.31%

Top labelers

CompanyDevicesShare
Five Star Orthodontic Laboratory & Supply Inc7437%
American Orthodontics Corporation5829%
Dentaurum Gmbh & Co.Kg2613%
Tp Orthodontics Inc136%
Dental Morelli Ltda136%
Allesee Aoa-Pro84%
Young Innovations, Inc.63%
Mk Meditech Inc.31%
Hangzhou Dtc Medical Apparatus Co., Ltd.10%

Company = labeler of record on GUDID. 9 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DTCDistal JetTMA Spring, Pk/10Distal Jet Springs, 240gr., Pk/10Distal Jet Set Screw, Pk/10AOA Standard RPE, 12mm, Pk/5PhD RPE with Sheaths, Pk/5Tracy Mini RPE with Sheaths, Pk/5AOA 2-Arm Mini RPE, 12mm, Pk/5Molar RotatorWilson 3D Lingual ArchWilson Multi-Action MandibularWilson Multi-Action PalatalNiti Palatal ExpanderCompact RPEPendex

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, ORTHODONTIC123
DYJRetainer, Screw Expansion, Orthodontic48
DZCWire, Orthodontic33
DZNINSTRUMENTS, DENTAL HAND13
ECPINSTRUMENT, LIGATURE TUCKING, ORTHODONTIC2
ECOSPRING, ORTHODONTIC2

GMDN & GCC registration

  • GMDN code 64769 · non‑implantable
  • Single‑use 93% · sterile 0% · Rx‑only 90% · 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 palate expander/teeth aligner, bonded products are registered in the US?

202 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic palate expander/teeth aligner, bonded", from 9 companies. The largest labeler is Five Star Orthodontic Laboratory & Supply Inc with 37% of records.

Which FDA product codes apply?

DYJ (RETAINER, SCREW EXPANSION, ORTHODONTIC), DYJ (Retainer, Screw Expansion, Orthodontic), DZC (Wire, Orthodontic), DZN (INSTRUMENTS, DENTAL HAND)

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.

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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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