FDA.reportPublic FDA data

WeCare Denture Cleanser, Antibacterial

Primary DI
00616784487724
Brand
WeCare Denture Cleanser, Antibacterial
Company
Dynarex Corporation
Model
4877
Device description
Kills Millions of Bacteria, Fight Odor, Removes Stains
Published
2025-09-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00616784487731PackageGS124In Commercial Distribution
00616784487724PrimaryGS10
00810180842273Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00616784487731006167844877316167844877310616784487731
00616784487724006167844877246167844877240616784487724
00810180842273008101808422738101808422730810180842273

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.

Regulatory Flags#

DUNS number
008124539
Device count
40
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840117343764Dynacare Necessities Complete Kit13742026-05-28
00616784812137Drape Sheets, Tissue 2-ply, White, 40" x 48"81212021-09-01
00616784812236Drape Sheets81222021-09-01
00616784812335Drape Sheets81232021-09-01
00616784813134Drape Sheets, Tissue 2-ply, White, 40" x 60"81312021-09-01
00616784813233Drape Sheets81322021-09-01
00616784813332Drape Sheets81332021-09-01
00616784814131Drape Sheets, Tissue 2-ply, White81412021-09-01
00616784815039Drape Sheets, Tissue 2-ply, Blue, 40" x 90"81502021-09-01
00616784815138Drape Sheets, Tissue 2-Ply, white, 40" x 90"81512021-09-01
00616784816135Pillow Cases, Tissue / Poly 2-ply, 21" x 30", White81612021-09-01
00616784890128SecureSafe Safety Insulin Syringe89012017-10-16
00616784890425SecureSafe Safety Insulin Syringe89042017-10-16
00616784892825SecureSafe Syringes With Safety Needle, Non-Toxic, 3 ML, Luer Lock89282017-10-16
00616784711720Disposable Ear Specula Tips For Diagnostic Otoscopes, Adult, 4.25 mm71172021-05-21
00616784418025Bandage Shears 7.5" (19.1 cm) Black41802020-11-08
00616784418124Bandage Shears 7.5" (19.1 cm) Blue41812020-11-08
00616784418223Bandage Shears 7.5" (19.1 cm) Magenta41822020-11-08
00616784418322Bandage Shears 7.5" (19.1 cm) Orange41832020-11-08
00616784418421Bandage Shears 7.5" (19.1 cm) Purple41842020-11-08

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
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
00814832015893EFFDNT PLUS MNT 44CT TAB 6Medtech Products Inc.EFT2022-11-16