Consulting Wallah › Device Explorer › Other devices › Orthodontic bracket adhesive
Device Explorer · FDA GUDID · GMDN 31750

Orthodontic bracket adhesive

A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.

US‑registered devices654in commercial distribution
Companies36labelers on GUDID
Single‑use50%of device records
Sterile0%labelled sterile
Prescription66%Rx‑only share
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Share of device records

Reliance Orthodontic Products Inc26240%
3M Unitek Corporation619%
Ormco Corporation315%
Five Star Orthodontic Laboratory & Supply Inc294%
Tp Orthodontics Inc284%
American Orthodontics Corporation274%
Rmo, Inc.193%
Dental Technologies, Inc.173%

Top labelers

CompanyDevicesShare
Reliance Orthodontic Products Inc26240%
3M Unitek Corporation619%
Ormco Corporation315%
Five Star Orthodontic Laboratory & Supply Inc294%
Tp Orthodontics Inc284%
American Orthodontics Corporation274%
Rmo, Inc.193%
Dental Technologies, Inc.173%
Septodont, Inc162%
Ortho Technology, Inc.162%
Orthoquest, Inc.152%
Orthosource132%

Company = labeler of record on GUDID. 36 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

PCA CEMENT KIT 60GM/40MLPCA CEMENT KIT 25GM/15MLGLASS IONOMER CEMENT KIT 15GM/15MLNovocol GRANITEC ORTHO ADH NOMIX 40-0.35G REFILLNovocol GRANITEC ORTHODONTIC ADH LC 40-0.35 REFNovocol GRANITEC PRIMER 9MLNovocol GRANITEC ORTHODONTC ADHESV NOMIX 3.5G/3MNovocol GRANITEC ORTHODONTIC ADHESIVE NOMIX 3.5GNovocol GRANITEC ORTHODONTIC ADHESIVE LC 3.5G/3MNovocol GRANITEC ORTHODONTIC ADHESIVE LC 1-3.5GNovocol GRANITEC MULTI CURE IONOMER 2 x 4.5GGRANITEC BLUE BAND CEMENT LIGHT CURE 5GNovocol GRANITEC BLUE BAND CEMENT LIGHT CURE KITNovocol GRANITEC ORTHODONTIC ADHESIVE NO MIXNovocol GRANITEC ORTHODNTIC ADHESIVE LIGHT-CURESmartBond LC

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

FDA product codes

CodeNameDevices
DYHAdhesive, Bracket And Tooth Conditioner, Resin369
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN252
EBFMaterial, Tooth Shade, Resin66
KLEAgent, Tooth Bonding, Resin38
EMACement, Dental24
EJFBRACKET, METAL, ORTHODONTIC12

GMDN & GCC registration

  • GMDN code 31750 · non‑implantable
  • Single‑use 50% · sterile 0% · Rx‑only 66% · 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

Weight (Gram) · 26Total Volume (Milliliter) · 7

Use these as the dimensions to specify in a tender line.

How many orthodontic bracket adhesive products are registered in the US?

654 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic bracket adhesive", from 36 companies. The largest labeler is Reliance Orthodontic Products Inc with 40% of records.

Which FDA product codes apply?

DYH (Adhesive, Bracket And Tooth Conditioner, Resin), DYH (ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN), EBF (Material, Tooth Shade, Resin), KLE (Agent, Tooth Bonding, 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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