Home GUDID D801SP556011 SciPharm Fastil Saliva-Cured Temporary Restorative
Primary DI D801SP556011
Brand SciPharm Fastil Saliva-Cured Temporary Restorative
Company SCIENTIFIC PHARMACEUTICALS, INC.
Model SP 55-601
Catalog number 55-601
Device description Fastfil - A Saliva-Cured Temporary Restorative.
Published 2016-08-09
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use 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 D801SP556011 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Fahrenheit 83 Degrees Fahrenheit
Regulatory Flags# DUNS number 096010525 Device count 1 Lot or batch true Manufacturing date on label true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published D801ID70125BI1 International Dental Supply Gel Etch Dental Conditioner ID 70-125 BI 70-125 2016-08-11 D801SP50013B1 SciPharm Dental Etching Agent Bottle SP 50-013 B 50-013 2016-07-06 D801SP50013N1 SciPharm Dental Etching Agent Bottle, Non-Boxed SP 50-013 N 50-013 2016-07-07 D801SP701211 SciPharm Gel Etch Dental Conditioner SP 70-121 70-121 2016-08-11 D801SP70125B1 SciPharm Gel Etch Dental Conditioner SP 70-125 B 70-125 2016-08-11 D801SP70125N1 SciPharm Gel Etch Dental Conditioner SP 70-125 N 70-125 2016-08-11 D801SP70125RB1 SciPharm Gel Etch Dental Conditioner SP 70-125 RB 70-125 2016-08-11 D801SP70125SB1 SciPharm Gel Etch Dental Conditioner SP 70-125 SB 70-125 2016-08-11 D801SP70128B1 SciPharm Gel Etch Dental Conditioner SP 70-125 B 70-128 2016-08-11 D801SP7012B1 SciPharm Gel Etch Dental Conditioner SP 70-12 B 70-12 2016-08-10 D801SP7012N1 SciPharm Gel Etch Dental Conditioner SP 70-12 N 70-12 2016-08-10 D801SP7012RB1 SciPharm Gel Etch Dental Conditioner SP 70-12 RB 70-12 2016-08-10 D801SP7012SB1 SciPharm Gel Etch Dental Conditioner SP 70-12 SB 70-12 2016-08-10 D801SP70130B1 SciPharm Gel Etch Dental Conditioner SP 70-130 B 70-130 2016-08-11 D801SP70130N1 SciPharm Gel Etch Dental Conditioner SP 70-130 N 70-130 2016-08-11 D801SP70143B1 SciPharm Gel Etch Dental Conditioner SP 70-143 B 70-143 2016-08-11 D801SP70143N1 SciPharm Gel Etch Dental Conditioner SP 70-143 N 70-143 2016-08-11 D801SP7014B1 SciPharm Gel Etch Dental Conditioner SP 70-14 B 70-14 2016-08-11 D801SP7014N1 SciPharm Gel Etch Dental Conditioner SP 70-14 N 70-14 2016-08-11 D801SP5505B1 SciPharm Diamond Luster Polishing Paste SP 55-05 B 55-05 2016-08-08
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
scipharm.com