Home GUDID D701ER502 ETCH ROYALE™ DENTAL ETCHING GEL
Primary DI D701ER502
Brand ETCH ROYALE™ DENTAL ETCHING GEL
Company PULPDENT CORPORATION
Model ER50
Device description Jumbo Kit: 2 x 25 mL syringes gel (64 gm), 5 x 3 mL empty syringes, 50 applicator tips37% Phosphoric Acid
Published 2016-08-11
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true Product Codes# Code, Name table Code Name KLE Agent, Tooth Bonding, Resin
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class KLE Agent, Tooth Bonding, Resin Dental 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status D701ER502 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Dental tooth-etching solution An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. After application, this device cannot be reused.
Device Sizes# Type, Value, Unit table Type Value Unit Total Volume 25 Milliliter
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 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 D701ET32 Etch Rite ET-3 ET-3 2021-05-17
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