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Device Explorer · FDA GUDID · GMDN 46582

Orthodontic bracket, plastic, single-use

A plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for

US‑registered devices3,531in commercial distribution
Companies13labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription100%Rx‑only share
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Share of device records

Ec Certification Service Gmbh2,33066%
G & H Wire Company, Inc.2978%
Flexmedics2808%
Ortho Organizers, Inc.2246%
American Orthodontics Corporation1103%
Ortho Technology, Inc.1093%
Rmo, Inc.652%
Ormco Corporation491%

Top labelers

CompanyDevicesShare
Ec Certification Service Gmbh2,33066%
G & H Wire Company, Inc.2978%
Flexmedics2808%
Ortho Organizers, Inc.2246%
American Orthodontics Corporation1103%
Ortho Technology, Inc.1093%
Rmo, Inc.652%
Ormco Corporation491%
Ortho Specialties461%
Six Month Smiles130%
Gestenco International Ab40%
Darby Dental Supply, Llc20%

Company = labeler of record on GUDID. 13 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

FreddySpringtimeBite-BumperSpirit MBSpiritMBDamon 3Darby Dental Supply, LLCAlicePremium LineComposite Clear EyeletsComp Plus Six™ 1 Case Lower Bracket Kit-Lab UseComp Plus Six™ 1 Case Upper Bracket Kit-Lab OnlyComp Plus Six™ 1 Case Bracket Kit-Lab Use.022 Comp Clear Six™ Brackets-1 Case Kit.022 Comp Clear Six™ Brackets-5 Case Kit.022 LR Cuspid Comp Clear Six™

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

FDA product codes

CodeNameDevices
DYWBracket, Plastic, Orthodontic3,056
DYWBRACKET, PLASTIC, ORTHODONTIC933
EJFBRACKET, METAL, ORTHODONTIC49
NJMBracket, ceramic, orthodontic2
NXCAligner, Sequential2
DZNINSTRUMENTS, DENTAL HAND1

GMDN & GCC registration

  • GMDN code 46582 · 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 bracket, plastic, single-use products are registered in the US?

3,531 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic bracket, plastic, single-use", from 13 companies. The largest labeler is Ec Certification Service Gmbh with 66% of records.

Which FDA product codes apply?

DYW (Bracket, Plastic, Orthodontic), DYW (BRACKET, PLASTIC, ORTHODONTIC), EJF (BRACKET, METAL, ORTHODONTIC), NJM (Bracket, ceramic, 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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