Home GUDID EMICCPCK1 EnaCem HF
Primary DI EMICCPCK1
Brand EnaCem HF
Company MICERIUM SPA
Model CPCK
Catalog number CPCK
Device description ENACEM HF+BONDING COMPLETE KIT1 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 gauge5 COSM3P-1 PLUG for NEEDLETUBE 20 gauge1 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 needle8 CPCTIPN-1 AUTOMIX ENACEM needle4 CPCTIPS-1 Intraoral Syringe Needle
Published 2021-12-02
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information Product Codes# Code, Name table Code Name DYH Adhesive, Bracket And Tooth Conditioner, Resin EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DYH Adhesive, Bracket And Tooth Conditioner, Resin Dental 2 EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status EMICCPCK1 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition 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 an aluminosilicate glass powder and an aqueous solution of a polyalkenoic acid. It typically includes some additional fillers, and may include setting substances that are in the minority (e.g., resin, metal). After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 2 Degrees Celsius 10 Degrees Celsius
Regulatory Flags# DUNS number 436661136 Device count 1 Kit true Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 08809262953602 EsCem Spident Co., Ltd. EMA 2026-04-29 08809262953619 EsCem Spident Co., Ltd. EMA 2026-04-29 08809262953626 EsCem Spident Co., Ltd. EMA 2026-04-29 08809262959208 EsCem RMGI Spident Co., Ltd. EMA 2026-04-20 08809262959215 EsCem RMGI Spident Co., Ltd. EMA 2026-04-20 08809262959222 EsCem RMGI Spident Co., Ltd. EMA 2026-04-20 08809262959239 EsCem RMGI Spident Co., Ltd. EMA 2026-04-20 08809911118505 NuSmile NuCem NUSMILE, LTD. EMA 2026-04-14 08809911118512 NuSmile NuCem NUSMILE, LTD. EMA 2026-04-14 07615208292855 Speedcem 100 IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2024-10-14 07615208293470 SpeedCEM / SpeedCEM Plus IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2024-10-14 07615208293487 SpeedCEM / SpeedCEM Plus IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2024-10-14 07615208294965 SpeedCEM / SpeedCEM Plus IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2024-10-14 07615208298659 Multilink Automix / Primer A+B IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2023-10-25 07615208298666 Multilink Automix / Primer A+B IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2023-04-06 07615208300833 Multilink Automix / Primer A+B IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2023-04-06 07615208315301 Telio Desensitizer IVOCLAR VIVADENT AKTIENGESELLSCHAFT EMA 2022-09-29 10386040003896 Miracle Mix® Gc America Inc. EMA 2022-07-13 10386040008655 GC Fuji ORTHO™ Gc America Inc. DYH 2022-07-13 10386040008716 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008723 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008730 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008747 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008754 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008761 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008778 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008785 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008792 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008808 GC Fuji II LC® Gc America Inc. EMA 2022-07-13 10386040008815 GC Fuji II LC® Gc America Inc. EMA 2022-07-13