FDA.reportPublic FDA data

DawnMist

Primary DI
00665973012902
Brand
DawnMist
Company
Dukal LLC
Model
DA2
Catalog number
DA2
Device description
Denture Adhesive Zinc Free 2.4 oz Tube
Published
2022-12-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10665973012909PackageGS136In Commercial Distribution
20665973012906PackageGS14In Commercial Distribution
00665973012902PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1066597301290910665973012909
2066597301290620665973012906
00665973012902006659730129026659730129020665973012902

GMDN Terms#

Term, Definition table
TermDefinition
Carboxymethylcellulose sodium/polymer denture adhesive, zinc-freeAn adhesive compound composed of carboxymethylcellulose sodium and a polymer (e.g., ethylene oxide homopolymer, cationic polyacrylamide polymer, polyvinyl methylether maleic acid salt), that does not contain zinc (i.e., no zinc salts), intended to be 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.

Contacts#

Phone, Email table
PhoneEmail
+1(631)656-3800kmckigney@dukal.com

Regulatory Flags#

DUNS number
791014871
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10665973032860DUKALUPST-050UPST-0502026-06-01
10665973032877DUKALUPST-075UPST-0752026-06-01
10665973032884DUKALUPST-100UPST-1002026-06-01
10665973027248Dukal27607276072022-12-06
20665973026675Dukal60409604092022-12-06
00665973027456Dukal700710470071042022-12-06
10665973032631Dukal550055002026-01-12
10665973032648Dukal550155012026-01-12
10665973032655Dukal550255022026-01-12
10665973032662Dukal550355032026-01-12
20665973032638Dukal550055002026-01-12
20665973032645Dukal550155012026-01-12
30665973032659Dukal550255022026-01-12
30665973032666Dukal550355032026-01-12
10665973033027Dukal553055302026-02-26
20665973033024Dukal553055302026-02-26
10665973018154American White Cross7665033 and 76900007665033 and 76900002022-12-07
10665973018178American White Cross767503376750332022-12-06
00665973022611Dukal985198512022-12-06
10665973020911Dukal11130111302026-01-30

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
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