FDA.reportPublic FDA data

Freshmint

Primary DI
00085317003852
Brand
Freshmint
Company
NEW WORLD IMPORTS, INC.
Model
DA2
Device description
Freshmint® 2.4 oz Denture Adhesive, Zinc Free, Extra Strength holding power with easy open cap
Published
2020-08-11
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

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
00085317003845PackageGS112In Commercial Distribution
00085317003852PackageGS16In Commercial Distribution
00085317003838PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085317003845000853170038450853170038450085317003845
00085317003852000853170038520853170038520085317003852
00085317003838000853170038380853170038380085317003838

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-329-1903Sales@newworldimports.com

Regulatory Flags#

DUNS number
075372276
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
00085317008918FreshmintFreshmint Floss Pick 90 Count BagFLSPK90362021-01-07
00085317008901FreshmintFreshmint Floss Pick 90 Count BagFLSPK90362021-01-07
00085317008642FreshmintFLSPK2020-08-13
00085317008635FreshmintFLSPK2020-08-13
00085317003715FreshmintDENT402020-08-11
00085317003838FreshmintDA22020-08-11
00085317004064FreshmintDF1002020-08-11
00085317004309FreshmintDENT902020-08-11
00085317005665FreshmintDA242020-08-11
00085317005795CareALLDA852020-08-11
00085317007942FreshmintDF122020-08-11
00085317008116FreshmintDFUW1002020-08-11
00085317003708FreshmintDENT402020-08-11
00085317007935FreshmintDF1002020-08-11
00085317004316FreshmintDENT902020-08-11
00085317005658FreshmintDA242020-08-11
00085317005788CareALLDA852020-08-11
00085317003739FreshmintDF122020-08-11
00085317008109FreshmintDFUW1002020-08-11

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
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