FDA.reportPublic FDA data

Tenure®

Primary DI
D8131146B0
Brand
Tenure®
Company
DEN-MAT HOLDINGS, LLC
Model
1146B
Catalog number
1146B
Device description
TENURE B ADHESIVE 6mL
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K872510000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K872510000DEN-MAT TENUREDen-Mat Corp.1987-08-24EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8131146B0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dentine bonding agent/setA material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material. It includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Cold storage recommended in tropical climates
Special Storage Condition, Specify00Do not expose to source of ignition or open flame
Special Storage Condition, Specify00Do not expose to direct sunlight
Special Storage Condition, Specify00Do not freeze
Special Storage Condition, Specify00Recommended temperature when used is 70-75
Storage Environment Temperature36 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-433-6628info@denmat.com

Regulatory Flags#

DUNS number
809857704
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8130303761050GBLOCK0303761052023-03-06
D8130303761100GBLOCK0303761102023-03-06
00359883007218EVANESCE0322200322202025-10-08
00359883005214Max Etch 35% Phosphoric Acid Etch 30mL3453023453022025-03-12
00359883005221Max Etch 35% Phosphoric Acid Etch 5mL3455033455032025-03-12
D8130301255000Ceri-Prime0301255000301255002016-09-24
D8130304025501Cerinate®0304025500304025502016-09-24
D8131002AB0Ceri-Prime1002AB1002AB2016-09-24
D8131398B0Ceri-Prime1398B1398B2016-09-24
D81313990Ceri-Prime139913992016-09-24
D813402022B0Other402022B402022B2016-09-24
D8134020600Ceri-Prime4020604020602016-09-24
D81340213100Ceri-Prime402131040213102016-09-24
00359883007201EVANESCE0322550322552025-05-30
00359883005665Tissue Goo™ Hemostatic Gel 4-Pack6419046419042025-03-18
00359883005672Tissue Goo™ Hemostatic Gel Big Shot Syringe Kit6419606419602025-03-18
00359883002053Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883002046Affinity™ Heavy Body RS 120ml 2-Pack0234010234012025-03-14
00359883006273Final Shine Cotton Polishing Wheel 50-Pack1335001335002025-03-13
00359883006501Clinician's Choice® G5 Sample Pack9726059726052025-03-13

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Primary DI, Brand, Company table
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07630243601301ParaCoreDent4You AGEBF2026-07-07
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07630243634750ParaCoreDent4You AGEBF2026-07-07
07630243634767ParaCoreDent4You AGEBF2026-07-07
07630243634774ParaCoreDent4You AGEBF2026-07-07
00348783000931MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000955MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000979MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783000993MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001044MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
00348783001051MultiMatchPREMIER DENTAL PRODUCTS COMPANYEBF2026-06-02
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06975338703081SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703098SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703104SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703357SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703364SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
06975338703371SHINING 3D®Hangzhou SHINING3D Dental Technology Co., Ltd.EBF2026-06-02
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