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Device Explorer · FDA GUDID · GMDN 65678

Orthodontic palate expander screw, self-removable

An orthodontic device intended to be used as part of a self-removable palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is not fixed to th

US‑registered devices109in commercial distribution
Companies4labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Dentaurum Gmbh & Co.Kg6761%
Scheu-Dental Gmbh1716%
Dental Morelli Ltda1716%
Allesee Aoa-Pro87%

Top labelers

CompanyDevicesShare
Dentaurum Gmbh & Co.Kg6761%
Scheu-Dental Gmbh1716%
Dental Morelli Ltda1716%
Allesee Aoa-Pro87%

Company = labeler of record on GUDID. 4 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PendulumPendexPhD ApplianceMDA ApplianceHex AppliancePenguinDistal Jet Molar UprighterSpring Jet ExpanderVECTOR® ScrewN.A.rematitan®Morelli

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, ORTHODONTIC84
DYJRetainer, Screw Expansion, Orthodontic23
KMYPOSITIONER, TOOTH, PREFORMED8

GMDN & GCC registration

  • GMDN code 65678 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 100% · 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 screw, self-removable products are registered in the US?

109 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic palate expander screw, self-removable", from 4 companies. The largest labeler is Dentaurum Gmbh & Co.Kg with 61% of records.

Which FDA product codes apply?

DYJ (RETAINER, SCREW EXPANSION, ORTHODONTIC), DYJ (Retainer, Screw Expansion, Orthodontic), KMY (POSITIONER, TOOTH, PREFORMED)

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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