Home GUDID D820ZEN0 Zenith Implant Screw Mask
Primary DI D820ZEN0
Brand Zenith Implant Screw Mask
Company DENALI CORPORATION
Model ZEN1
Catalog number ZEN
Device description Dental Implant Screw Mask
Published 2023-06-13
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 D820ZEN1 Package HIBCC 2 In Commercial Distribution D820ZEN0 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.
Regulatory Flags# DUNS number 191036107 Device count 1 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 D820DETCH120 Denali Etching Gel 12 mL Etching Gel DETCH12 2016-08-05 D820DETCH30 Denali Etching Gel Syringe 3 mL DETCH3 2016-08-05 D820ZEN1 Zenith Implant Screw Mask ZEN1 ZEN 2023-06-13 D820HIRO0 HIRO Light Cure Pattern, Modeling and Indexing Resin One 3 mL Syringe HIRO 2018-01-09 D820JAZ0 Jazzy DC Acrylic Resin Single Double-Barrel Syringe JAZ 2018-01-09 D820BONOW0 Bonita Pit and Fissure Sealant 1.2 mL Opaque White BONOW 2016-08-05 D820ACOREEOW0 AuraCore Buildup Material Single - Opaque White COREEOW 2016-08-04 D820ACORENOW0 AuraCore Buildup Material Single - Natural Off White ACORENOW 2016-08-04 D820ALAYNT0 AuraLay Pit & Fissure Sealant 1.2 mL Natural Translucent ALAYNT 2016-08-05 D820ALAYNT3ML0 AuraLay Pit and Fissure Sealant 3 mL Natural Translucent ALAYNT3ML 2016-08-05 D820ALAYOW0 AuraLay Pit and Fissure Sealant Opaque White 2016-08-05 D820ALAYOW3ML0 AuraLay Pit and Fissure Sealant 3 mL Opaque White ALAYOW3ML 2016-08-05 D820ALAYXFNT0 AuraLay XF Pit and Fissure Sealant 1.2 mL Natural Translucent ALAYXFNT 2016-08-05 D820ALAYXFNT3ML0 AuraLay XF Pit and Fissure Sealant 3 mL Natural Translucent ALAYXFNT3 2016-08-05 D820ALAYXFOW0 AuraLay XF Pit and Fissure Sealant 1.2 mL Opaque White ALAYXFOW 2016-08-05 D820ALAYXFOW3ML0 AuraLay XF Pit and Fissure Sealant 3 mL Opaque White 2016-08-05 D820APS0 Aura Protective Sealer 1.2 mL Clear APS 2016-08-05 D820BONNT0 Bonita Pit and Fissure Sealant 1.2 mL Natural Translucent BONNT 2016-08-05 D820BONOW1 Bonita Pit and Fissure Sealant 1.2 mL Opaque White BONOW 2016-08-05 D820CV0 ClearVue Pit & Fissure Sealant and Sealer 1.2 mL Clear CV 2016-08-05
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