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Device Explorer · FDA GUDID · GMDN 35863

Alginate dental impression material

A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and

US‑registered devices412in commercial distribution
Companies38labelers on GUDID
Single‑use36%of device records
Sterile0%labelled sterile
Prescription64%Rx‑only share
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Share of device records

Mdc Dental4411%
Henry Schein, Inc.4310%
Dental Technologies, Inc.328%
Cavex Holland B.V.277%
Kerr Corporation266%
Flexmedics225%
Major Prodotti Dentari Spa215%
Harry J Bosworth Company184%

Top labelers

CompanyDevicesShare
Mdc Dental4411%
Henry Schein, Inc.4310%
Dental Technologies, Inc.328%
Cavex Holland B.V.277%
Kerr Corporation266%
Flexmedics225%
Major Prodotti Dentari Spa215%
Harry J Bosworth Company184%
Dentsply International Inc.174%
Lascod Spa174%
Benco Dental Supply Co.143%
Hexa Dental133%

Company = labeler of record on GUDID. 38 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

VIVID JELBLU JELMDC DentalESSENTIALSMIMICBISICO ChrominatPLASTALGINCavex Water Dosing Bottle BlueCavex Alginate Container PinkCavex Alginate Container BluePowder scoop + Water measurePowder scoop + Water measure NeutralCavex Plastic Container Lid BlueCavex Mixing SpatulaCavex Mixing Bowl BlueCavex Plastic Container Box

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

FDA product codes

CodeNameDevices
ELWMATERIAL, IMPRESSION272
ELWMaterial, Impression248
EIDSYRINGE, RESTORATIVE AND IMPRESSION MATERIAL6
EJRAGENT, POLISHING, ABRASIVE, ORAL CAVITY4
EHKCup, Prophylaxis3

GMDN & GCC registration

  • GMDN code 35863 · non‑implantable
  • Single‑use 36% · sterile 0% · Rx‑only 64% · OTC 6%
  • 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) · 89Weight (Kilogram) · 41Weight (Pound) · 33Total Volume (Milliliter) · 10Total Volume (Fluid Ounce) · 1

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

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

412 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Alginate dental impression material", from 38 companies. The largest labeler is Mdc Dental with 11% of records.

Which FDA product codes apply?

ELW (MATERIAL, IMPRESSION), ELW (Material, Impression), EID (SYRINGE, RESTORATIVE AND IMPRESSION MATERIAL), EJR (AGENT, POLISHING, ABRASIVE, ORAL CAVITY)

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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