FDA.reportPublic FDA data

TS1 Tongue Vacuum Cleaner

Primary DI
D2486300621
Brand
TS1 Tongue Vacuum Cleaner
Company
HAGER WORLDWIDE, INC.
Model
630062
Device description
Tongue scraper
Published
2024-08-20
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
LCNSCRAPER, TONGUE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCNScraper, TongueDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D2486300621PrimaryHIBCC0
D2486300620Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Tongue scraper, single-useA non-sterile device designed to scrape the upper surface of the tongue to promote oral hygiene (e.g., to remove plaque, food debris, and bacteria, and to prevent bad breath). It is normally available [non-prescription] over-the-counter (OTC). It is typically made of plastic and is available in a variety of designs (e.g., a U-shaped band or a T-shaped instrument), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a single-use device.

Regulatory Flags#

DUNS number
009277971
Device count
50
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D2486058711Hager Prophy Brush Regular Flat6058712026-05-12
D2486058701Hager Prophy Brush Fine Flat6058702026-05-12
D248938521Uni-Wedge Regular ( Orange)938522026-01-28
D248938520Uni-Wedge Regular ( Orange)938522026-01-28
D2481009320"""Heidi"" Protective Eyewear "1009322025-10-22
D2481009330"""Ella"" Protective Eyewear "1009332025-10-22
D2481009350"""Lucy"" Protective Eyewear "1009352025-10-22
D2483552480BurButler (5-Hole Pink Base w/Lid)3552482025-10-22
D2483552490BurButler (5-Hole Purple Base w/Lid)3552492025-10-22
D2483552500BurButler (5-Hole White Base w/Lid)3552502025-10-22
D2483552510BurButler (5-Hole Blue Base w/Lid)3552512025-10-22
D2483552550BurButler (10-Hole Orange Base w/Lid)3552552025-10-22
D2483552570BurButler (10-Hole Black Base w/Lid)3552572025-10-22
D2483552580BurButler (10-Hole Purple Base w/Lid)3552582025-10-22
D2483552590BurButler (25-Hole White Base w/Lid)3552592025-10-22
D2483552610BurButler (25-Hole Purple Base w/Lid)3552612025-10-22
D2483552630BurButler (25-Hole Orange Base w/Lid)3552632025-10-22
D2483552640BurButler (25-Hole Black Base w/Lid)3552642025-10-22
D2483552650BurButler (25-Hole Orange Base w/ Tall Lid)3552652025-10-22
D2483552660BurButler (25-Hole Blue Base w/ Tall Lid)3552662025-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131044725Adult SuperScraper SilverSupermouth LLCLCN2025-06-30
00810131044732Adult SuperScraper Rose GoldSupermouth LLCLCN2025-06-30
10304040192488Henry ScheinHENRY SCHEIN, INC.LCN2025-06-27
00304040192481Henry ScheinHENRY SCHEIN, INC.LCN2025-06-27
00810131041502Adult Resuable Tongue Scraper Supermouth LLCLCN2025-05-25
00810131041519Ortho Resuable Tongue Scraper SilverSupermouth LLCLCN2025-05-25
00810131041526Ortho Resuable Tongue Scraper Rose GoldSupermouth LLCLCN2025-05-25
00817612021008Dale Scrape-n-Suction Tongue CleanerDale Medical Products, Inc.LCN2024-12-02
00070942007849GUM® SUNSTAR AMERICAS, INC.LCN2024-10-30
D2486300620TS1 Tongue Vacuum CleanerHAGER WORLDWIDE, INC.LCN2024-08-20
00810131040529Ortho Tongue scraper SilverSupermouth LLCLCN2024-06-01
00810131040536Ortho Tongue scraper Rose GoldSupermouth LLCLCN2024-06-01
00850036799511Chocolate Kids Tongue Scraper Single ScoopSupermouth LLCLCN2024-06-01
00850036799528Strawberry Kids Tongue Scraper Single ScoopSupermouth LLCLCN2024-06-01
00850036799535Vanilla Kids Tongue Scraper Single ScoopSupermouth LLCLCN2024-06-01
00850036799542Chocolate Kids Tongue Scraper Double ScoopsSupermouth LLCLCN2024-06-01
00850036799559Strawberry Kids Tongue Scraper Double ScoopsSupermouth LLCLCN2024-06-01
00850036799566Vanilla Kids Tongue Scraper Double ScoopsSupermouth LLCLCN2024-06-01
00850036799603Adult Tongue ScraperSupermouth LLCLCN2024-06-01
06975983272130MomcozyShenzhen Lutejiacheng Supply Chain Management Co., Ltd.LCN2024-03-27
08908022377037PerforaCHIPPER CONSUMER PRIVATE LIMITEDLCN2023-08-04
00723896023679Plastic Tongue CleanersPRACTICON, INC.LCN2023-06-08
00723896023686Plastic Tongue CleanersPRACTICON, INC.LCN2023-06-08
10818207022964Vista tongue CleanersVista DentalLCN2022-09-01
07895742228293MorelliDental Morelli LtdaLCN2022-03-21
07895742228309MorelliDental Morelli LtdaLCN2022-03-21
00858290006642Elevate Tongue Cleaner Metal Green w/Pink and Blue BandsELEVATE ORAL CARE, LLCLCN2021-07-28
00858290006659Elevate Tongue Cleaner Metal 6pkELEVATE ORAL CARE, LLCLCN2021-07-28
00050428272695CVS HealthWOONSOCKET PRESCRIPTION CENTER, INCORPORATEDLCN2020-12-02
00817612021015Dale Strapless Bendable ArmboardDALE MEDICAL PRODUCTS, INC.LCN2020-09-14