FDA.reportPublic FDA data

AuraLay XF Pit and Fissure Sealant

Primary DI
D820ALAYXFNT3ML0
Brand
AuraLay XF Pit and Fissure Sealant
Company
DENALI CORPORATION
Model
3 mL Natural Translucent
Catalog number
ALAYXFNT3
Device description
Pit and Fissure Sealant
Published
2016-08-05
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
EBCSealant, Pit And Fissure, And Conditioner

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBCSealant, Pit And Fissure, And ConditionerDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071158000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071158000AURALAY PIT & FISSURE SEALANTDenali Corporation2007-06-05EBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D820ALAYXFNT3ML1PackageHIBCC2In Commercial Distribution
D820ALAYXFNT3ML2PackageHIBCC4In Commercial Distribution
D820ALAYXFNT3ML0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental pit/fissure sealantA resin-based dental material suitable for sealing pits and fissures on teeth. It may be chemically cured or external energy cured. 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
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
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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