Home GUDID 10841396102223 Maxcem Elite Chroma
Primary DI 10841396102223
Brand Maxcem Elite Chroma
Company Kerr Corporation
Model 36301
Device description Universal Resin Cement with Cleanup Indicator. Syringes, 4:1 Automix Tips (Regular, Wide) and Intraoral Tips
Published 2020-05-26
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 10841396102223 Primary GS1 0 00841396102226 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 10841396102223 10841396102223 00841396102226 00841396102226 841396102226 0841396102226
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.
Device Sizes# Type, Value, Unit table Type Value Unit Weight 10 Gram
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 4 Degrees Celsius 25 Degrees Celsius
Regulatory Flags# DUNS number 199354556 Device count 2 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