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Device Explorer · FDA GUDID · GMDN 16658

Dental impression material adhesive

A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.

US‑registered devices52in commercial distribution
Companies20labelers on GUDID
Single‑use10%of device records
Sterile0%labelled sterile
Prescription92%Rx‑only share
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Share of device records

3M Deutschland Gmbh2650%
Kettenbach Gmbh & Co. Kg36%
Henry Schein, Inc.36%
Darby Dental Supply, Llc24%
Ultradent Products, Inc.24%
Gc America Inc.24%
Clinician'S Choice Dental Products, Inc.12%
Harvard Dental International Gmbh12%

Top labelers

CompanyDevicesShare
3M Deutschland Gmbh2650%
Kettenbach Gmbh & Co. Kg36%
Henry Schein, Inc.36%
Darby Dental Supply, Llc24%
Ultradent Products, Inc.24%
Gc America Inc.24%
Clinician'S Choice Dental Products, Inc.12%
Harvard Dental International Gmbh12%
Dmg Chemisch-Pharmazeutische Fabrik Gmbh12%
Evolve Dental Technologies, Inc.12%
Cargus International, Inc12%
Young Innovations, Inc.12%

Company = labeler of record on GUDID. 20 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Affinity™ Tray AdhesiveHarvard TraySiveTray Adhesive for A-SiliconesImpregum™ Super Quick3M™ ESPE™ Impregum™3M™3M™ Imprint™Imprint™ 4 Super Quick HeavyImprint™ 4 Penta™ HeavyImpregum™ Penta™ Soft Heavy BodyImpregum™ SoftImpregum™ Penta™ Soft Medium BodyUniversal AdhesiveIdentium AdhesivePanasil AdhesiveDarby Dental Supply, LLC

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

FDA product codes

CodeNameDevices
ELWMATERIAL, IMPRESSION22
EBHMATERIAL, IMPRESSION TRAY, RESIN15
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL13
ELWMaterial, Impression8
EBHMaterial, Impression Tray, Resin7
EHYTRAY, IMPRESSION, PREFORMED5

GMDN & GCC registration

  • GMDN code 16658 · non‑implantable
  • Single‑use 10% · sterile 0% · Rx‑only 92% · 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) · 6

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

How many dental impression material adhesive products are registered in the US?

52 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Dental impression material adhesive", from 20 companies. The largest labeler is 3M Deutschland Gmbh with 50% of records.

Which FDA product codes apply?

ELW (MATERIAL, IMPRESSION), EBH (MATERIAL, IMPRESSION TRAY, RESIN), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), ELW (Material, Impression)

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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