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Device Explorer · FDA GUDID · GMDN 65677

Orthodontic palate expander screw, bonded

An orthodontic device intended to be used as part of a bonded 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 intended to remain in t

US‑registered devices178in commercial distribution
Companies7labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Dentaurum Gmbh & Co.Kg14984%
Allesee Aoa-Pro116%
Young Innovations, Inc.63%
Tiger Dental Gmbh53%
Scheu-Dental Gmbh42%
Great Lakes Dental Technologies, Ltd.21%
Specialty Appliances, Llc11%

Top labelers

CompanyDevicesShare
Dentaurum Gmbh & Co.Kg14984%
Allesee Aoa-Pro116%
Young Innovations, Inc.63%
Tiger Dental Gmbh53%
Scheu-Dental Gmbh42%
Great Lakes Dental Technologies, Ltd.21%
Specialty Appliances, Llc11%

Company = labeler of record on GUDID. 7 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Fan ExpanderFrozatArnold ExpanderW Arch ExpanderBi-HelixWilson 3D ApplianceHaas ExpanderDeLuke Bonded Frameless ExpanderLower ExpanderQuad HelixRapid Palatal ExpanderMini-Palex Screw 12mmThe Orthodontic StoreMARPEVECTOR® ScrewN.A.

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, ORTHODONTIC172
DYJRetainer, Screw Expansion, Orthodontic21
KMYPOSITIONER, TOOTH, PREFORMED16
PNNOrthodontic Software2
DYWBRACKET, PLASTIC, ORTHODONTIC1

GMDN & GCC registration

  • GMDN code 65677 · non‑implantable
  • Single‑use 99% · 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 palate expander screw, bonded products are registered in the US?

178 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic palate expander screw, bonded", from 7 companies. The largest labeler is Dentaurum Gmbh & Co.Kg with 84% of records.

Which FDA product codes apply?

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

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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