Consulting Wallah › Device Explorer › Procedure kits & trays › Orthodontic aligner auxiliary attachment kit
Device Explorer · FDA GUDID · GMDN 44732

Orthodontic aligner auxiliary attachment kit

A collection of devices, used with retainer-style orthodontic appliances (e.g., preformed teeth aligners) to further facilitate and enhance teeth alignment. The kit includes buttons and elastics, typically made of clear materials for aesthetic purposes, that a

US‑registered devices50in commercial distribution
Companies8labelers on GUDID
Single‑use98%of device records
Sterile2%labelled sterile
Prescription96%Rx‑only share
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Share of device records

Ortho Arch Company Inc2142%
3M Unitek Corporation1632%
Reliance Orthodontic Products Inc510%
Align Technology, Inc.48%
Sino Medical Sciences Technology Inc.12%
Arcadlab12%
Straight-T Llc12%
Dental Morelli Ltda12%

Top labelers

CompanyDevicesShare
Ortho Arch Company Inc2142%
3M Unitek Corporation1632%
Reliance Orthodontic Products Inc510%
Align Technology, Inc.48%
Sino Medical Sciences Technology Inc.12%
Arcadlab12%
Straight-T Llc12%
Dental Morelli Ltda12%

Company = labeler of record on GUDID. 8 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

NC ROCKSTARArcad AlignersStraight T Clear Dental AlignerERUPTION APPLIANCEBITE RAMPLINGUAL CLEATSLINGUAL CLEATWELDABLE LINGUALELAS-O-LOOPDIRECT BONDLINGUAL SHEATHLINGUAL SHEATHS WELDEDLN BONDABLEMICRO DIRECT BONDDIRECT BOND TONGUECOMPOSITE DIRECT BOND

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

FDA product codes

CodeNameDevices
NXCAligner, Sequential21
ECQAligner, Bracket, Orthodontic21
ECOSpring, Orthodontic4
KXRApplicator, Resin3
DYTMaintainer, Space Preformed, Orthodontic2
LOXCatheters, Transluminal Coronary Angioplasty, Percutaneous1

GMDN & GCC registration

  • GMDN code 44732 · non‑implantable
  • Single‑use 98% · sterile 2% · 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.

No closely related category with 50+ devices.

How many orthodontic aligner auxiliary attachment kit products are registered in the US?

50 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic aligner auxiliary attachment kit", from 8 companies. The largest labeler is Ortho Arch Company Inc with 42% of records.

Which FDA product codes apply?

NXC (Aligner, Sequential), ECQ (Aligner, Bracket, Orthodontic), ECO (Spring, Orthodontic), KXR (Applicator, Resin)

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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