Who else makes this device?

Name: EsCem
Brand: EsCem

EsCem

EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that…

Registry build 21.09.26

EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with ‘one step’ system that does not need pre-treatment process. It is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2 mm Al). And it offers various shades for aesthetics and color stable.

3manufacturers in China registered for this device type

3catalogue 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
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	2026-04-29

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
Catalogue number	Size	Status
EsCem A3		In distribution
EsCem A2		In distribution
EsCem TW		In distribution

Same Product Code

Other products under the same FDA product code
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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.