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Device Explorer · FDA GUDID · GMDN 42483

Dentine adhesive

A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.

US‑registered devices133in commercial distribution
Companies16labelers on GUDID
Single‑use45%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Scientific Pharmaceuticals, Inc.4836%
Ultradent Products, Inc.1612%
Dentsply International Inc.1612%
Pulpdent Corporation1310%
Tokuyama Dental Corporation97%
Gc America Inc.65%
Voco Gmbh43%
Henry Schein, Inc.43%

Top labelers

CompanyDevicesShare
Scientific Pharmaceuticals, Inc.4836%
Ultradent Products, Inc.1612%
Dentsply International Inc.1612%
Pulpdent Corporation1310%
Tokuyama Dental Corporation97%
Gc America Inc.65%
Voco Gmbh43%
Henry Schein, Inc.43%
Darby Dental Supply, Llc32%
Benco Dental Supply Co.32%
Dentsply De Trey Gmbh32%
Kerr Corporation22%

Company = labeler of record on GUDID. 16 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Tokuyama Bond ForceOne-UP Bond F PlusAdmira FusionGrandio SOAdmira BondDarby Dental Supply, LLCSample Hands On Bonding KitPermaFlo DCPeak SEPeak Universal BondBondLinkSciPharm Cure-On Touch Orthodontic AdhesiveSciPharm Band Secure Orthodontic Band CementSciPharm CuRay Eclipse Visible Light-Cured OrthoSciPharm Seal and Bond OrthodonticInternational Dental Supply CuRay Match Visible

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

FDA product codes

CodeNameDevices
KLEAGENT, TOOTH BONDING, RESIN49
DYHAdhesive, Bracket And Tooth Conditioner, Resin48
KLEAgent, Tooth Bonding, Resin29
EMACement, Dental5
EBFMaterial, Tooth Shade, Resin4
EMACEMENT, DENTAL1

GMDN & GCC registration

  • GMDN code 42483 · non‑implantable
  • Single‑use 45% · sterile 0% · Rx‑only 98% · 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) · 31Weight (Gram) · 1

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

How many dentine adhesive products are registered in the US?

133 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dentine adhesive", from 16 companies. The largest labeler is Scientific Pharmaceuticals, Inc. with 36% of records.

Which FDA product codes apply?

KLE (AGENT, TOOTH BONDING, RESIN), DYH (Adhesive, Bracket And Tooth Conditioner, Resin), KLE (Agent, Tooth Bonding, Resin), EMA (Cement, Dental)

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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