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Device Explorer · FDA GUDID · GMDN 62200

Zinc oxide eugenol dental cement

A non-aqueous substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between

US‑registered devices89in commercial distribution
Companies21labelers on GUDID
Single‑use53%of device records
Sterile0%labelled sterile
Prescription54%Rx‑only share
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Share of device records

Temrex Corporation2022%
Dentsply International Inc.1011%
Produits Dentaires S.A.910%
Maquira Industria De Produtos Odontologicos S/A78%
Prevest Denpro Limited56%
Keystone Industries56%
Associated Dental Products Limited44%
Axiodent Inc.44%

Top labelers

CompanyDevicesShare
Temrex Corporation2022%
Dentsply International Inc.1011%
Produits Dentaires S.A.910%
Maquira Industria De Produtos Odontologicos S/A78%
Prevest Denpro Limited56%
Keystone Industries56%
Associated Dental Products Limited44%
Axiodent Inc.44%
Hexa Dental33%
Cargus International, Inc33%
First Scientific Dental Materials Gmbh22%
Dmg Chemisch-Pharmazeutische Fabrik Gmbh22%

Company = labeler of record on GUDID. 21 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Oxford Temp CEM UniversalOxford Temp CEM Flexi-TransAlganol Powder 90gZinc Oxide B.P. Powder 150gEugenol B.P. Liquid 150mlZonalin Complete Quick Set Pack 28g/10mlTempoCem® AutomixZitempZinconolZoer QuickZoer ReinforcedHexa DentalZOE PLUSZINROC POWDERZINROC LIQUIDTEMREX POWDER

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

FDA product codes

CodeNameDevices
EMBZinc Oxide Eugenol44
EMACement, Dental31
EMBZINC OXIDE EUGENOL12
EMACEMENT, DENTAL9
NDPAccessories, implant, dental, endosseous1

GMDN & GCC registration

  • GMDN code 62200 · non‑implantable
  • Single‑use 53% · sterile 0% · Rx‑only 54% · OTC 8%
  • 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) · 14Total Volume (Milliliter) · 7

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

How many zinc oxide eugenol dental cement products are registered in the US?

89 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Zinc oxide eugenol dental cement", from 21 companies. The largest labeler is Temrex Corporation with 22% of records.

Which FDA product codes apply?

EMB (Zinc Oxide Eugenol), EMA (Cement, Dental), EMB (ZINC OXIDE EUGENOL), 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.

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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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