FDA.reportPublic FDA data

Affinity™ Tray Adhesive

Primary DI
07540172016797
Brand
Affinity™ Tray Adhesive
Company
CLINICIAN'S CHOICE DENTAL PRODUCTS, INC.
Model
034300
Catalog number
034300
Device description
Adherant for impression materials and plastic trays
Published
2019-07-12
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
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540172019255Direct MarkingGS10
07540172016797PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540172019255075401720192557540172019255
07540172016797075401720167977540172016797

GMDN Terms#

Term, Definition table
TermDefinition
Dental impression 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
Device Size Text, specify0
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)265-3444info@clinicianschoice.com

Regulatory Flags#

DUNS number
626406016
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540172009539Frost™ 37% Phosphoric Acid Etch 30ml3453013453012016-09-16
07540172009546Frost™ 37% Phosphoric Acid Etch 5ml3455013455012016-09-16
07540172010795Max Etch 35% Phosphoric Acid Etch 30ml3453023453022016-09-16
07540172010801Max Etch 35% Phosphoric Acid Etch 5ml3455033455032016-09-16
07540172019125G5 All-Purpose Desensitizer2261052261052024-09-23
07540172019132G5 All-Purpose Desensitizer2261102261102024-09-23
07540172019514Evanesce™ Nano-Enhanced Universal Restorative A2U Single Dose Sample9732129732122024-09-17
07540172019644Evanesce™ Silk Nano-Enhanced Universal Restorative A1E Single Dose3235703235702024-09-17
07540172019651Evanesce™ Silk Nano-Enhanced Universal Restorative A2E Single Dose3235713235712024-09-17
07540172019668Evanesce™ Silk Nano-Enhanced Universal Restorative A3E Single Dose3235723235722024-09-17
07540172019675Evanesce™ Silk Nano-Enhanced Universal Restorative B1E Single Dose3235733235732024-09-17
07540172019682Evanesce™ Silk Nano-Enhanced Universal Restorative A2D Single Dose3235743235742024-09-17
07540172019699Evanesce™ Silk Nano-Enhanced Universal Restorative A3D Single Dose3235753235752024-09-17
07540172019705Evanesce™ Silk Nano-Enhanced Universal Restorative B2U Single Dose3235763235762024-09-17
07540172019712Evanesce™ Silk Nano-Enhanced Universal Restorative C2U Single Dose3235773235772024-09-17
07540172019729Evanesce™ Silk Nano-Enhanced Universal Restorative A2U Single Dose Sample9732119732112024-09-17
07540172019507MPa Universal™ Light-Cure Universal Adhesive Unit Dose Sample9732669732662024-08-09
07540172002363Green Mouldable Edentulous Trays Size 211884211884212020-10-22
07540172001861D-Fine Double Diamond™ Primary Polisher Refill #091315091315092020-10-22
07540172001953D-Fine Double Diamond™ Final High Shine Refill #091325091325092020-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00732953170249Staydent SHEFFIELD PHARMACEUTICALS, LLCKOO2025-06-09
00359883006594Affinity™ Tray AdhesiveDEN-MAT HOLDINGS, LLCKOO2025-03-12
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