Home GUDID 00197998079955 Solventum™ Durelon™
Primary DI 00197998079955
Brand Solventum™ Durelon™
Company Solventum Germany GmbH
Model 38237
Catalog number 38237
Device description Solventum™ Durelon™ Zinc Polycarboxylate Luting Cement Radiopaque Triple Pack Powder, 38237, 20 g, 3/PAC
Published 2026-10-08
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use false 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 00197998079955 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 00197998079955 00197998079955 197998079955 0197998079955
GMDN Terms# Term, Definition table Term Definition Zinc polycarboxylate dental cement A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.
Regulatory Flags# DUNS number 315518329 Device count 1 DM exempt false Premarket exempt true HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label true Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00197998079917 Solventum™ Durelon™ Solventum Germany GmbH EMA 2026-10-08 00197998079962 Solventum™ Durelon™ Solventum Germany GmbH EMA 2026-10-08 00197998079986 Solventum™ Durelon™ Solventum Germany GmbH EMA 2026-10-08 00197998079993 Solventum™ Durelon™ Solventum Germany GmbH EMA 2026-10-08 00197998080005 Solventum™ Durelon™ Solventum Germany GmbH EMA 2026-10-08 00197998099984 Solventum™ RelyX™ Solventum Germany GmbH EMA 2026-10-08 00197998226724 Solventum™ Protemp™ Solventum Germany GmbH EMA 2026-10-08 00810118108082 NuSmile BioCem NUSMILE, LTD. EMA 2026-09-22 00766054002956 CEMPOWER ESSENTIAL DENTAL SYSTEMS, INC. EMA 2026-09-21 00195062162565 Cement-It Kerr Corporation EMA 2026-07-29 00195062162572 Cement-It Kerr Corporation EMA 2026-07-29 00195062162589 Cement-It Kerr Corporation EMA 2026-07-29 08809911118529 NuSmile NuCem NUSMILE, LTD. EMA 2026-07-21 08809911118550 NuSmile NuCem NUSMILE, LTD. EMA 2026-07-21 08806383591737 DIA-CEM DiaDent Group International EMA 2026-07-20 08806383591751 DIA-CEM DiaDent Group International EMA 2026-07-20 08806383591775 DIA-CEM DiaDent Group International EMA 2026-07-20 08806383591959 DIA-CEM DiaDent Group International EMA 2026-07-20 08806383591966 DIA-CEM DiaDent Group International EMA 2026-07-20 08806383591973 DIA-CEM DiaDent Group International EMA 2026-07-20 04548162300836 ResiCem EX SHOFU DENTAL CORPORATION EMA 2026-07-04 04548162300843 ResiCem EX SHOFU DENTAL CORPORATION EMA 2026-07-04 04548162300850 ResiCem EX SHOFU DENTAL CORPORATION EMA 2026-07-04 04548162300867 ResiCem EX SHOFU DENTAL CORPORATION EMA 2026-07-04 04548162344113 ResiCem EX SHOFU DENTAL CORPORATION EMA 2026-07-04 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
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