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Device Explorer · FDA GUDID · GMDN 34782

Dentine bonding agent/set

A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may als

US‑registered devices5,548in commercial distribution
Companies78labelers on GUDID
Single‑use90%of device records
Sterile0%labelled sterile
Prescription12%Rx‑only share
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Share of device records

Liaoning Upcera Co.,Ltd.4,80987%
Kuraray Noritake Dental Inc.701%
Ivoclar Vivadent Aktiengesellschaft561%
3M Deutschland Gmbh461%
Kerr Corporation381%
Bisco Inc.331%
Gc America Inc.291%
Voco Gmbh281%

Top labelers

CompanyDevicesShare
Liaoning Upcera Co.,Ltd.4,80987%
Kuraray Noritake Dental Inc.701%
Ivoclar Vivadent Aktiengesellschaft561%
3M Deutschland Gmbh461%
Kerr Corporation381%
Bisco Inc.331%
Gc America Inc.291%
Voco Gmbh281%
Vista Dental281%
Den-Mat Holdings, Llc260%
Reliance Orthodontic Products Inc200%
Kulzer Gmbh200%

Company = labeler of record on GUDID. 78 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SyntacMultilink Automix / Primer A+BMonobond PlusExciTE FAdhese UniversalMonobond Etch & PrimeAdhese 100HeliobondSelect SE-Bond LCMPa Universal™ Light-Cure Universal Adhesive UniMPa Universal™ Dual-Cure CatalystMPa Universal™ Light-Cure Universal Adhesive 5mLMPa Universal™ Light-Cure Universal Adhesive UniMPa™ Max Adhesive with Chlorhexidine KitMPa™ Max Adhesive with ChlorhexidineAuto-Cure Activator

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

FDA product codes

CodeNameDevices
EBFMaterial, Tooth Shade, Resin4,837
KLEAGENT, TOOTH BONDING, RESIN389
KLEAgent, Tooth Bonding, Resin386
DYHAdhesive, Bracket And Tooth Conditioner, Resin57
EMACEMENT, DENTAL32
KXRAPPLICATOR, RESIN31

GMDN & GCC registration

  • GMDN code 34782 · non‑implantable
  • Single‑use 90% · sterile 0% · Rx‑only 12% · 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

Total Volume (Milliliter) · 99Weight (Gram) · 8

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

How many dentine bonding agent/set products are registered in the US?

5,548 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dentine bonding agent/set", from 78 companies. The largest labeler is Liaoning Upcera Co.,Ltd. with 87% of records.

Which FDA product codes apply?

EBF (Material, Tooth Shade, Resin), KLE (AGENT, TOOTH BONDING, RESIN), KLE (Agent, Tooth Bonding, Resin), DYH (Adhesive, Bracket And Tooth Conditioner, 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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