Home GUDID D701IFU2 GlassFill™
Primary DI D701IFU2
Brand GlassFill™
Company PULPDENT CORPORATION
Model IFU
Device description Glass Ionomer Cement - Universal Shade30 gm Powder, 15 mL liquid, scoop, mixing pad
Published 2016-09-01
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D701IFU2 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.
Regulatory Flags# DUNS number 001006089 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D701DEN2 DENTIN CONDITIONING GEL DEN 2016-07-21 D701EA2 ETCH-ALL™ EA 2016-09-01 D701EA52 ETCH-ALL™ Dental Etching Gel EA5 2016-07-28 D701ER2 ETCH ROYALE™ DENTAL ETCHING GEL ER 2016-08-11 D701ER242 ETCH ROYALE™ DENTAL ETCHING GEL ER24 2016-08-11 D701ER502 ETCH ROYALE™ DENTAL ETCHING GEL ER50 2016-08-11 D701ER50R2 Etch Royale ER50R 2016-09-01 D701ER62 ETCH ROYALE™ DENTAL ETCHING GEL ER6 2016-08-11 D701ET122 ETCH-RITE™ DENTAL ETCHING GEL ET12 2016-07-28 D701ET12G2 ETCH-RITE™ DENTAL ETCHING GEL ET12G 2016-07-28 D701ET182 ETCHANT ET18 2016-09-01 D701ET242 ETCH-RITE™ DENTAL ETCHING GEL ET24 2016-08-11 D701ET502 ETCH-RITE™ DENTAL ETCHING GEL ET50 2016-08-11 D701ET50R2 ETCH-RITE™ DENTAL ETCHING GEL ET50R 2016-08-11 D701ET62 ETCH-RITE™ DENTAL ETCHING GEL ET6 2016-07-28 D701ETCH2 ETCH-RITE™ DENTAL ETCHING GEL ETCH 2016-07-28 D701ETTWIN2 ETCH-RITE™ DENTAL ETCHING GEL ETTWIN 2016-07-28 D701SER2 ETCH ROYALE SAMPLE SER 2018-08-10 D701SETCH2 ETCH RITE SAMPLE SETCH 2018-08-10 D701ET1442 ETCH-RITE™ DENTAL ETCHING GEL ET144 2016-08-11
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 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 10386040008822 GC Fuji II LC® Gc America Inc. EMA 2022-07-13