FDA.reportPublic FDA data

AuraCore Buildup Material

Primary DI
D820ACORENOW0
Brand
AuraCore Buildup Material
Company
DENALI CORPORATION
Model
Single - Natural Off White
Catalog number
ACORENOW
Device description
Core Buildup Material, Dental.
Published
2016-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070702000FUSION RESIN CEMENT AND CORE KITDenali Corporation2007-05-10EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D820ACORENOW0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1-781-826-9190denalicorp@denalicorporation.com

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 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
D820HIRO0HIRO Light Cure Pattern, Modeling and Indexing ResinOne 3 mL SyringeHIRO2018-01-09
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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