Who else makes this device?

Name: Glass Ionomer Cement (Filling)
Brand: Glass Ionomer Cement (Filling)

Glass Ionomer Cement (Filling)

Glass Ionomer Cement (Filling) is a self-curing dental cement supplied as a powder and liquid system. The powder includes silica, alumina and strontium fluoride, while the liquid contains…

Registry build 21.09.26

Glass Ionomer Cement (Filling) is a self-curing dental cement supplied as a powder and liquid system. The powder includes silica, alumina and strontium fluoride, while the liquid contains polycarboxylic acid. Mixing initiates an acid-base reaction that forms the filling material.

The cement is radiopaque and intended for restoration of primary teeth, Class III and V cavities, and limited Class I cavities. It can also serve as a base lining beneath composite or amalgam restorations and as a core build-up material.

Filling Types and Limits

The range includes Filling I and Filling II formulations for permanent or temporary fillings and base linings. Pulp capping is excluded. The filling cement has its own restoration indications; the separate luting cement indications for cementing crowns, bridges or posts do not apply to this product.

3manufacturers in China registered for this device type

2catalogue numbers in this listing

2510(k) clearances naming this product code

Who Else Makes It

Concentrated in Shandong (2), Guangdong (1).

Chinese manufacturers registered for FDA product code EMA
Manufacturer	City	Province	Registered as	Device types
Shandong Huge Dental Material Corporation	Rizhao	Shandong	Manufacturer	17
Rizhao Huge Biomaterials Company, Ltd.	Rizhao	Shandong	Manufacturer	7
Shenzhen Upcera Dental Technology Co., Ltd.	Shenzhen	Guangdong	Private-label distributor	6

Record

Regulatory record for Glass Ionomer Cement (Filling)
Listed by	Shandong Huge Dental Material Corporation, China
FDA product code	EMA
Device type	Cement, Dental
Device class	Class 2
Regulation	21 CFR 872.3275
Establishment	Manufacturer, Exporter
510(k)	K160345
Record published	2017-11-17
Record revised	2026-04-16 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number, expiry date

Catalogue Numbers

Catalogue numbers for Glass Ionomer Cement (Filling)
Catalogue number	Size	Status
Filling I, Filling II		In distribution
Filling I, Filling II		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
GC Fuji II LC®	GC America Inc.	78
Equia®	GC America Inc.	73
Riva SC	SDI Ltd.	72
Denture Base	American Tooth Industries	61
Riva LC	SDI Ltd.	59
GC Fuji IX GP®	GC America Inc.	58
GlasIonomer FX-LC	Shofu Dental Corp.	45
Henry Schein	Henry Schein, Inc.	35
Esthet-X®flow Liquid Micro Hybrid	Dentsply LLC	24
Photac™ Fil Quick Aplicap™	3M Deutschland GmbH	24
Ketac™ Fil Plus Aplicap™	3M Deutschland GmbH	23
Ultra-Bond®	DEN-MAT Holdings, LLC	23

Showing 12 of 780. All products under Cement, Dental

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K160345	2017-03-03
K161851	2016-10-31

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.