FDA.reportPublic FDA data

CareALL

Primary DI
00085317005795
Brand
CareALL
Company
NEW WORLD IMPORTS, INC.
Model
DA85
Device description
CareALL® .85 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

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
00085317005771PackageGS13In Commercial Distribution
00085317005788PackageGS124In Commercial Distribution
00085317005795PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085317005771000853170057710853170057710085317005771
00085317005788000853170057880853170057880085317005788
00085317005795000853170057950853170057950085317005795

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
800-329-1903Sales@newworldimports.com

Regulatory Flags#

DUNS number
075372276
Device count
1
Premarket exempt
true

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
00085317007942FreshmintDF122020-08-11
00085317008116FreshmintDFUW1002020-08-11
00085317003708FreshmintDENT402020-08-11
00085317003852FreshmintDA22020-08-11
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
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