Consulting Wallah › Device Explorer › Dental › Zinc polycarboxylate dental cement
Device Explorer · FDA GUDID · GMDN 16705

Zinc polycarboxylate dental cement

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

US‑registered devices78in commercial distribution
Companies17labelers on GUDID
Single‑use15%of device records
Sterile0%labelled sterile
Prescription85%Rx‑only share
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Share of device records

3M Deutschland Gmbh2228%
Ultradent Products, Inc.810%
Henry Schein, Inc.79%
Harvard Dental International Gmbh68%
Shofu Dental Corporation68%
Pearson Dental Supplies, Inc.68%
Solventum Germany Gmbh68%
Dentonics Inc34%

Top labelers

CompanyDevicesShare
3M Deutschland Gmbh2228%
Ultradent Products, Inc.810%
Henry Schein, Inc.79%
Harvard Dental International Gmbh68%
Shofu Dental Corporation68%
Pearson Dental Supplies, Inc.68%
Solventum Germany Gmbh68%
Dentonics Inc34%
Iq Dental Supply Llc34%
Bisico Bielefelder Dentalsilicone Gmbh & Co. Kg23%
3D Dental Designs And Development, Llc23%
Dentsply International Inc.23%

Company = labeler of record on GUDID. 17 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Harvard Polycarboxylat Cement, Single liquidHarvard Polycarboxylat Cement, Single powder, ShHarvard Polycarboxylat Cement, Single powder, ShHarvard Polycarboxylat Cement, Clinic liquidHarvard Polycarboxylat Cement, Clinic powder, ShHarvard Polycarboxylat Cement, Clinic powder, ShZCEM CarbProvi Bond, 25 mlProvi Bond, 5 mlDurelon™Durelon™ Maxicap™ZOE Temporary Liquid 12mL (SDC Catalogue)ZOE Temporary Powder 20g (SDC Catalogue)Zinc Oxide Eugenol(ZOE) Temporary Cement kitPolycarboxylateHY-Bond Polycarboxylate Cement

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

FDA product codes

CodeNameDevices
EMACEMENT, DENTAL45
EMACement, Dental31
EJKLiner, Cavity, Calcium Hydroxide1

GMDN & GCC registration

  • GMDN code 16705 · non‑implantable
  • Single‑use 15% · sterile 0% · Rx‑only 85% · OTC 1%
  • 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) · 7

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

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

78 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Zinc polycarboxylate dental cement", from 17 companies. The largest labeler is 3M Deutschland Gmbh with 28% of records.

Which FDA product codes apply?

EMA (CEMENT, DENTAL), EMA (Cement, Dental), EJK (Liner, Cavity, Calcium Hydroxide)

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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