FDA.reportPublic FDA data

Dyna Care Denture Adhesive

Primary DI
00616784486512
Brand
Dyna Care Denture Adhesive
Company
Dynarex Corporation
Model
4865
Device description
2 oz. tube
Published
2022-08-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
00616784486536PackageGS172In Commercial Distribution
00616784486512PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784486536006167844865366167844865360616784486536
00616784486512006167844865126167844865120616784486512

GMDN Terms#

Term, Definition table
TermDefinition
Polyvinyl methylether maleic acid calcium-sodium double salt denture adhesiveAn adhesive compound composed of polyvinyl methylether maleic acid calcium-sodium double salt used to stabilize a removable prosthesis in the mouth, particularly a denture, by adhering the prosthesis to the oral mucosa. The compound is typically applied to the base of a denture before it is inserted in the mouth. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
008124539
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117305670Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Adult/Pediatric310012021-04-22
00840117305694Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310022021-04-22
00840117305717Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310102021-04-22
00840117305731Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310112021-04-22
00840117305755Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310122021-04-22
00840117305779Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310212021-04-22
00840117305786Resp-O2 Closed Suction Endotracheal Catheter, T-Piece, Adult310222021-04-22
00840117305809Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310322021-04-22
00840117318144Resp-O2 Closed Suction Endotracheal Catheters, Sterile310202021-04-22
00840117318168Resp-O2 Closed Suction Endotracheal Catheter Double Swivel Elbow (DSE)310302021-04-22
00840117319462Resp-O2 Closed Suction Tracheal Catheter, T-Piece, Adult310032021-04-22
00840117319486Resp-O2 Closed Suction Tracheal Catheter, Double Swivel Elbow (DSE)310132021-04-22
00840117319523Resp-O2 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310332021-04-22
00840117319547Resp-O2 Closed Suction Tracheal Catheters, T-Piece, Pediatric310002021-04-22
00840117344129Resp-O2 Vexta72 Closed Suction Tracheal Catheter, T-Piece, Pediatric310042025-10-27
00840117344204Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Pediatric310242026-05-18
00840117344211Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult/Pediatric310252026-05-18
00840117344228Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, T-Piece, Adult310262026-05-18
00840117344242Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310342026-05-18
00840117344259Resp-O2 Vexta72 Closed Suction Endotracheal Catheter, Double Swivel Elbow (DSE)310352026-05-18

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
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