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Device Explorer · FDA GUDID · GMDN 16704

Glass ionomer dental cement

A non-sterile 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 devices1,381in commercial distribution
Companies49labelers on GUDID
Single‑use56%of device records
Sterile0%labelled sterile
Prescription76%Rx‑only share
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Share of device records

Gc America Inc.34625%
Liaoning Upcera Co.,Ltd.22716%
3M Deutschland Gmbh16212%
Sdi Limited1068%
Shofu Dental Corporation1027%
Silmet Ltd574%
3M Company554%
Voco Gmbh443%

Top labelers

CompanyDevicesShare
Gc America Inc.34625%
Liaoning Upcera Co.,Ltd.22716%
3M Deutschland Gmbh16212%
Sdi Limited1068%
Shofu Dental Corporation1027%
Silmet Ltd574%
3M Company554%
Voco Gmbh443%
Scientific Pharmaceuticals, Inc.413%
Advanced Healthcare Ltd.302%
Harvard Dental International Gmbh272%
Reliance Orthodontic Products Inc161%

Company = labeler of record on GUDID. 49 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Ceramir® Restore QuikCapCeramir Bioceramic Implant Cement QuikCapCeramir Crown & Bridge QuikCapCeramir Crown & Bridge QuikMixProGlassProGlass PlusProBaseProGlass NineProGlass Two LCProGlass TwoProGlass OneProGlass SilverGlass Ionomer Cement (Luting)Glass Ionomer Cement (Filling)Dental Lithium Disilicate Glass Ceramic Block(UpDental Lithium Disilicate Glass Ceramic Block(Up

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

FDA product codes

CodeNameDevices
EMACEMENT, DENTAL771
EMACement, Dental352
EIHPowder, Porcelain227
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN46
EBFMATERIAL, TOOTH SHADE, RESIN22
EBCSEALANT, PIT AND FISSURE, AND CONDITIONER20

GMDN & GCC registration

  • GMDN code 16704 · non‑implantable
  • Single‑use 56% · sterile 0% · Rx‑only 76% · OTC 2%
  • 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) · 79Total Volume (Milliliter) · 34Weight (Milligram) · 6

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

How many glass ionomer dental cement products are registered in the US?

1,381 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Glass ionomer dental cement", from 49 companies. The largest labeler is Gc America Inc. with 25% of records.

Which FDA product codes apply?

EMA (CEMENT, DENTAL), EMA (Cement, Dental), EIH (Powder, Porcelain), DYH (ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN)

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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