FDA.reportPublic FDA data

Freshmint

Primary DI
00085317003715
Brand
Freshmint
Company
NEW WORLD IMPORTS, INC.
Model
DENT40
Device description
Freshmint® 40 ct Denture Cleanser Tablets. Each Tablet Individually wrapped
Published
2020-08-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EFTCleanser, Denture, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFTCleanser, Denture, Over The CounterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00085317003708PackageGS124In Commercial Distribution
00085317003715PrimaryGS10
00085317008697Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00085317003708000853170037080853170037080085317003708
00085317003715000853170037150853170037150085317003715
00085317008697000853170086970853170086970085317008697

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleanserAn agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

Contacts#

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

Regulatory Flags#

DUNS number
075372276
Device count
40
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
00085317003838FreshmintDA22020-08-11
00085317004064FreshmintDF1002020-08-11
00085317004309FreshmintDENT902020-08-11
00085317005665FreshmintDA242020-08-11
00085317005795CareALLDA852020-08-11
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
00810051088649GuruNanda Aligner and Denture Cleaning FoamGurunanda, LLCEFT2026-04-29
00810194403972AiraAIRA, LLCEFT2026-01-16
10810194403979AiraAIRA, LLCEFT2026-01-16
00850078989307SmileSet Universal Cleaning Tablets – 90 pcOrtho Dental Lab LLCEFT2025-09-25
00850078989314SmileSet Universal Cleaning Tablets - Sample 6pcOrtho Dental Lab LLCEFT2025-09-17
00616784487724WeCare Denture Cleanser, Antibacterial Dynarex CorporationEFT2025-09-01
00810180842273WeCare Denture Cleanser, Antibacterial Dynarex CorporationEFT2025-09-01
00855850008061SmilesaverSoluria II LLCEFT2024-06-19
00855850008078SmilesaverSoluria II LLCEFT2024-06-19
00855850008092Guard HealthSoluria II LLCEFT2024-06-19
00855850008108SmilesaverSoluria II LLCEFT2024-06-19
00364031300165SECURE Cleansing TabletsFITTYDENT INTERNATIONAL GmbHEFT2023-10-02
D832200451PlasdentPLASDENT CORPORATIONEFT2023-05-31
D832200450PlasdentPLASDENT CORPORATIONEFT2023-05-31
00665973010878DawnMistDukal LLCEFT2022-12-06
00665973010885DawnMistDukal LLCEFT2022-12-06
D784UZM30011UnipackUNIPACK MEDICAL CORPORATIONEFT2022-12-06
06943566100118Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
06943566107391Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
20665973010872DawnMistDukal LLCEFT2022-12-06
20665973010889DawnMistDukal LLCEFT2022-12-06
00816063021407Cleaning Crystals, PacketteAlign Technology, Inc.EFT2022-12-06
16943566100115Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
16943566107398Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
D784UZM30015UnipackUNIPACK MEDICAL CORPORATIONEFT2022-12-06
00814832015879EFFERDENT ORIGINAL 102CT TAB 6Medtech Products Inc.EFT2022-11-17
00814832015923EFFERDENT PM 90CT TAB 6Medtech Products Inc.EFT2022-11-17
10814832015876EFFERDENT ORIGINAL 102CT TAB 6MEDTECH PRODUCTS INC.EFT2022-11-17
10814832015920EFFERDENT PM 90CT TAB 6MEDTECH PRODUCTS INC.EFT2022-11-17
00814832015862EFFDNT ORIG 44CT TAB 6Medtech Products Inc.EFT2022-11-16