Home GUDID 00817051021850 Tempit
Primary DI 00817051021850
Brand Tempit
Company CENTRIX, INC.
Model 310031
Device description Tempit-E Temporary Filling & Sealing Material with Eugenol
Published 2023-12-29
Public version status New
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 00817051021850 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00817051021850 00817051021850 817051021850 0817051021850
GMDN Terms# Term, Definition table Term Definition Hygroscopic dental cement A substance intended for professional use as a dental cement (e.g., luting agent, liner, base, pulp-capping material, root canal sealer) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction of a hygroscopic inorganic compound(s) [e.g., calcium silicates, calcium aluminates, zinc sulfate, calcium sulfate] with water (hydration). It is intended to be either mixed with water prior to application or react with dentinal fluid in situ. After application, this device cannot be reused.
Regulatory Flags# DUNS number 053707303 Device count 1 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 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