AuraLay XF Pit and Fissure Sealant

Primary DI
D820ALAYXFOW0
Brand
AuraLay XF Pit and Fissure Sealant
Company
DENALI CORPORATION
Model
1.2 mL Opaque White
Catalog number
ALAYXFOW
Device description
Pit and Fissure Sealant, Dental.
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
D820ALAYXFOW1PackageHIBCC4In Commercial Distribution
D820ALAYXFOW2PackageHIBCC12In Commercial Distribution
D820ALAYXFOW3PackageHIBCC20In Commercial Distribution
D820ALAYXFOW0PrimaryHIBCC0

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
D820ALAYXFNT3ML0AuraLay XF Pit and Fissure Sealant3 mL Natural TranslucentALAYXFNT32016-08-05
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
306058610660213M™ Clinpro™3M COMPANYEBC2026-04-17
306058610660833M™ Clinpro™3M COMPANYEBC2026-04-17
07899633835232Vittra APS Unique FlowDentscare LtdaEBC2024-11-26
08806387860044Jet Flow Bulk UniversalMeta Biomed Co., Ltd.EBC2024-11-16
08806387860051Jet Flow Bulk A1Meta Biomed Co., Ltd.EBC2024-11-16
08806387860068Jet Flow Bulk A2Meta Biomed Co., Ltd.EBC2024-11-16
08806387860075Jet Flow Bulk A3Meta Biomed Co., Ltd.EBC2024-11-16
08806387860136Jet Flow Bulk DentinMeta Biomed Co., Ltd.EBC2024-11-16
D77819950611Scott's Select ColorFil Flow Single-Shade PrismaticSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
D77819950631Scott's Select ColorFil Flow BlockerSCOTT'S DENTAL SUPPLY L.L.C.EBC2024-08-27
07615208294187Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294194Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294200Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208294217Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2024-04-04
07615208301335Helioseal/Clear/F/F PlusIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBC2023-04-06
H6686050011iSmileHarry J Bosworth CompanyEBC2023-02-20
306058610689263M™ Clinpro™3M COMPANYEBC2022-12-08
00810111542418OpaquerBISCO INC.EBC2022-10-11
00810111540629Choice 2BISCO INC.EBC2022-10-11
00810111540612Choice 2BISCO INC.EBC2022-10-10
00810111540872Duo-Link UniversalBISCO INC.EBC2022-10-10
00810111542302eCementBISCO INC.EBC2022-10-10
00810111542319eCementBISCO INC.EBC2022-10-10
00810111540117Porcelain PrimerBISCO INC.EBC2022-09-30
00810111540605Choice 2BISCO INC.EBC2022-08-02
D79645420MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
D7964542CS1MARK3CARGUS INTERNATIONAL, INCEBC2021-07-01
D757C3900KEU1Choice 2BISCO INC.EBC2021-06-25
D757C52410KEU1eCementBISCO INC.EBC2021-06-25
00815619021526EXACTA Flow-lcEXACTA DENTAL PRODUCTS INCEBC2019-02-01