FDA.reportPublic FDA data

Dyna Care Denture Adhesive

Primary DI
00616784486536
Brand
Dyna Care Denture Adhesive
Company
DYNAREX CORPORATION
Model
4865
Device description
2 oz. tube
Published
2022-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
008124539
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117341913Steel Button Folding Walker, Adult, With 5" Wheel, 32" - 39"10170-42026-08-03
00840117338067Resp-O2 M24 Oxygen E-Cylinder With CGA 870 Toggle Valve, 4.55 L36390-T2024-07-25
00840117338135Resp-O2 M15 Oxygen Standard D-Cylinder 2.89 L, With CGA 870 Post Valve363942024-07-25
00840117326156Resp-O2 M9 Oxygen C-Cylinder 1.7L363922023-12-29
00840117327511Resp-O2 M6 Oxygen B-Cylinder,1L With CGA870 Post Valve363932023-12-29
00840117327528Resp-O2 M15 Oxygen D-Cylinder, 2.9 L With CGA 870 Post Valve363912023-12-29
00840117326125Resp-O2 M24 Oxygen E-Cylinder, With CGA870 Post Valve363902023-03-24
00840117310162Resp-O2 Fingertip Pulse Oximeter, For Adult Use364002021-12-22
00840117341241Aluminum Crutches, Child, 4'0" - 4'6"10100-82026-07-31
00840117341258Aluminum Crutches, Youth, 4'6" - 5'2"10101-82026-07-31
00840117341265Aluminum Crutches, Adult, 5'2" - 5'10"10102-82026-07-31
00840117341272Aluminum Crutches, Tall, 5'10" - 6'6"10103-82026-07-31
00840117341357Forearm Crutches, Youth, 4'2" - 5'2"10110-62026-07-31
00840117341364Forearm Crutches, Adult, 5'0" - 6'2"10111-62026-07-31
00840117341371Forearm Crutches, Tall, 5'10" - 6'6"10112-62026-07-31
00840117346253Pill Crusher Pouches with Round Corners4210R2026-07-31
00840117349551Drape Sheets, Polypropylene/Polyethylene 2-ply, Black, 40" x 90" (101.6 cm x 22881562026-07-31
00840117350069Pillow Cases, Polypropylene/Polyethylene 2-ply, Black, 21" x 30"81672026-07-31
00840117351684Universal Catheterization Procedure Trays with 2000 mL Anti-Reflux Drainage Bag50032026-07-31
00840117351875Resp-O2 Single Suction Catheters, Pediatric Graduated Catheter32000S2026-07-31

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
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