Who else makes this device?

Name: EsCem Rmgi
Brand: EsCem Rmgi

EsCem Rmgi

EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure…

Registry build 21.09.26

EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.

3manufacturers in China registered for this device type

4catalogue numbers in this listing

4510(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 EsCem Rmgi
Listed by	Spident Co., Ltd., South Korea
FDA product code	EMA
Device type	Cement, Dental
Device class	Class 2
Regulation	21 CFR 872.3275
Establishment	Repacker / relabeller, Manufacturer, Exporter
Record published	2026-04-20

Specifications

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

Catalogue Numbers

Catalogue numbers for EsCem Rmgi
Catalogue number	Per pack	Status
EsCem RMGI 9g x 1sy		In distribution
EsCem RMGI 9g x 2sy	2	In distribution
EsCem RMGI 3g x 1sy		In distribution
EsCem RMGI 9g x 3sy	3	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
K250566	2025-06-20
K214076	2022-12-19
K134021	2014-06-10
K100290	2010-02-17

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.