Home GUDID D701HC2 HARDCORE®
Primary DI D701HC2
Brand HARDCORE®
Company PULPDENT CORPORATION
Model HC
Device description CORE BUILD-UP MATERIAL - DUAL CURE, FLUORIDE RELEASINGKIT: 20 gm base + 20 gm dual catalyst, 20 core forms, mixing pad, spatulas
Published 2016-09-01
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name EBF Material, Tooth Shade, Resin EMA Cement, Dental
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class EBF Material, Tooth Shade, Resin Dental 2 EMA Cement, Dental Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D701HC2 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.
Device Sizes# Type, Value, Unit table Type Value Unit Weight 20 Gram
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
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