FDA.reportPublic FDA data

HIRO Light Cure Pattern, Modeling and Indexing Resin

Primary DI
D820HIRO0
Brand
HIRO Light Cure Pattern, Modeling and Indexing Resin
Company
DENALI CORPORATION
Model
One 3 mL Syringe
Catalog number
HIRO
Device description
Light Cure Pattern, Modeling and Indexing Resin.
Published
2018-01-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EKODenture Preformed (Partially Prefabricated Denture)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EKODenture Preformed (Partially Prefabricated Denture)Dental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D820HIRO1PackageHIBCC2In Commercial Distribution
D820HIRO0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
191036107
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D820DETCH120Denali Etching Gel12 mL Etching GelDETCH122016-08-05
D820DETCH30Denali Etching GelSyringe 3 mLDETCH32016-08-05
D820ZEN0Zenith Implant Screw MaskZEN1ZEN2023-06-13
D820ZEN1Zenith Implant Screw MaskZEN1ZEN2023-06-13
D820JAZ0Jazzy DC Acrylic ResinSingle Double-Barrel SyringeJAZ2018-01-09
D820BONOW0Bonita Pit and Fissure Sealant1.2 mL Opaque WhiteBONOW2016-08-05
D820ACOREEOW0AuraCore Buildup MaterialSingle - Opaque WhiteCOREEOW2016-08-04
D820ACORENOW0AuraCore Buildup MaterialSingle - Natural Off WhiteACORENOW2016-08-04
D820ALAYNT0AuraLay Pit & Fissure Sealant 1.2 mL Natural TranslucentALAYNT2016-08-05
D820ALAYNT3ML0AuraLay Pit and Fissure Sealant3 mL Natural TranslucentALAYNT3ML2016-08-05
D820ALAYOW0AuraLay Pit and Fissure SealantOpaque White2016-08-05
D820ALAYOW3ML0AuraLay Pit and Fissure Sealant3 mL Opaque WhiteALAYOW3ML2016-08-05
D820ALAYXFNT0AuraLay XF Pit and Fissure Sealant1.2 mL Natural TranslucentALAYXFNT2016-08-05
D820ALAYXFNT3ML0AuraLay XF Pit and Fissure Sealant3 mL Natural TranslucentALAYXFNT32016-08-05
D820ALAYXFOW0AuraLay XF Pit and Fissure Sealant1.2 mL Opaque WhiteALAYXFOW2016-08-05
D820ALAYXFOW3ML0AuraLay XF Pit and Fissure Sealant3 mL Opaque White2016-08-05
D820APS0Aura Protective Sealer1.2 mL ClearAPS2016-08-05
D820BONNT0Bonita Pit and Fissure Sealant1.2 mL Natural TranslucentBONNT2016-08-05
D820BONOW1Bonita Pit and Fissure Sealant1.2 mL Opaque WhiteBONOW2016-08-05
D820CV0ClearVue Pit & Fissure Sealant and Sealer1.2 mL ClearCV2016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D7091032138Baltic Denture System BDCreatorMerz Dental GmbHEKO2017-11-25
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D7091032229Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032230Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032231Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032232Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032233Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032234Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
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D7091032248Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032249Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032250Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032251Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032252Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032253Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032254Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032255Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03
D7091032256Baltic Denture System BD LoadMerz Dental GmbHEKO2017-05-03