Who else makes this device?

Name: EnaCem HF
Brand: EnaCem HF

EnaCem HF

ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5…

Registry build 21.09.26

ENACEM HF+BONDING COMPLETE KIT 1 COS101 1 Ena Etch Orthophosphoric acid 37% 2ml 1 COSM101K CANULA 0,4 x 18mm. 1 COSM300A2 ENABOND Bonding Agent MONO 2ml 1 COSM300D-2 ENABOND Catalyst 2ml 5 COSM3A-1 ORANGE NEEDLETUBE 20 gauge 5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge 1 CPC-3UD1 ENACEM HF DUAL CEMENT UD1 3g 1 CPC-3UD2 ENACEM HF DUAL CEMENT UD2 3g 1 CPC-3UD3 ENACEM HF DUAL CEMENT UD3 3g 1 CPC-3UD4 ENACEM HF DUAL CEMENT UD4 3g 5 CPCTIPL-1 White Syringe needle 8 CPCTIPN-1 AUTOMIX ENACEM needle 4 CPCTIPS-1 Intraoral Syringe Needle

3manufacturers in China registered for this device type

1catalogue number

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 EnaCem HF
Listed by	Micerium SPA
FDA product code	EMA
Device type	Cement, Dental
Device class	Class 2
Regulation	21 CFR 872.3275
510(k)	K062355
Record published	2021-12-02

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date, manufacturing date
Storage	Handling environment temperature 2 to 10 °C

Catalogue Numbers

Catalogue numbers for EnaCem HF
Catalogue number	Size	Status
CPCK		In distribution

Same Product Code

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Riva LC	SDI Ltd.	59
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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
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Ultra-Bond®	DEN-MAT Holdings, LLC	23

Showing 12 of 780. All products under Cement, Dental

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.