FDA.reportPublic FDA data

Affinity™ Tray Adhesive

Primary DI
00359883006594
Brand
Affinity™ Tray Adhesive
Company
DEN-MAT HOLDINGS, LLC
Model
034300
Catalog number
034300
Device description
Adherant for impression materials and plastic trays
Published
2025-03-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KOOADHESIVE, DENTURE, POLYVINYL METHYLETHER MALEIC ACID CALCIUM-SODIUM DOUBLE SALT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOOAdhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double SaltDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992001000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992001000TRAY-LINKSilicon-Und Composite Spezialitaten GmbH1999-11-02ELW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00359883006594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00359883006594003598830065943598830065940359883006594

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression material adhesiveA liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume30Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sources of ignition. Protected from light. Store in well ventilated place.
Storage Environment Temperature15 Degrees Celsius25 Degrees Celsius

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732953170249Staydent SHEFFIELD PHARMACEUTICALS, LLCKOO2025-06-09
00364031300103SECURE Denture AdhesiveFITTYDENT INTERNATIONAL GmbHKOO2023-10-02
00364031300202SECURE Denture Adhesive SensitiveFITTYDENT INTERNATIONAL GmbHKOO2023-10-02
00850039396014RexallDOLGENCORP, LLCKOO2023-08-31
00665973012902DawnMistDukal LLCKOO2022-12-06
10665973012909DawnMistDukal LLCKOO2022-12-06
00616784486512Dyna Care Denture Adhesive Dynarex CorporationKOO2022-08-15
00616784486536Dyna Care Denture Adhesive DYNAREX CORPORATIONKOO2022-08-15
00857331000021DG HealthDOLGENCORP, LLCKOO2020-08-31
00085317003838FreshmintNEW WORLD IMPORTS, INC.KOO2020-08-11
00085317005665FreshmintNEW WORLD IMPORTS, INC.KOO2020-08-11
00085317005795CareALLNEW WORLD IMPORTS, INC.KOO2020-08-11
00085317003852FreshmintNEW WORLD IMPORTS, INC.KOO2020-08-11
00085317005658FreshmintNEW WORLD IMPORTS, INC.KOO2020-08-11
00085317005788CareALLNEW WORLD IMPORTS, INC.KOO2020-08-11
07540172016797Affinity™ Tray AdhesiveCLINICIAN'S CHOICE DENTAL PRODUCTS, INC.KOO2019-07-12