FDA.reportPublic FDA data

Elevate Tongue Cleaner Pink

Primary DI
00858290006031
Brand
Elevate Tongue Cleaner Pink
Company
ELEVATE ORAL CARE, LLC
Model
655PINK00
Device description
Elevate Tongue Cleaner Pink
Published
2019-01-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00858290006031PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858290006031008582900060318582900060310858290006031

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002863526
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858290006987Allday Oral Moisturizing Rinse, 10oz Bottle626MR10102026-05-01
00858290006970FluoriMax 2.5% NaF demo pack 630FMFT042026-01-28
00858290006802Advantage Arrest635GE30002025-07-21
00858290006819Advantage Arrest635GSP0502025-07-21
00858290006826Advantage Arrest635GSP0502025-07-21
00858290006956Advantage Arrest Advantage Arrest SDF 38% Gel Syringe 2.8ml Kit635GEL2802025-06-11
00858290006734FluoriMax Cotton CandyFlow Through Ampoule 70 pack6300070222024-12-12
00858290006918PapacariePapacarie Syringe610PAP1002024-12-12
00858290006932Povi-OnePovi-One/FluoriMax Varnish BG Convenience640POFM802024-12-12
00858290006659Elevate Tongue Cleaner Metal 6pk655METAL62021-07-28
00858290006444Smart Advantage GI Sample A1 and A2 pk675UD02002019-06-10
00858290006543Denteshield Primer 3ml Kit685PRM3002020-04-01
00858290006550Denteshield Primer 7ml Kit685PRM7002020-04-01
00858290006369Smart Advantage GI A1 ampule575CAPA1S2019-06-10
00858290006376Smart Advantage GI A2 ampoule575CAPA2S2019-06-10
00858290006352Smart Advantage GI A1 and A2 Combo kit 30 ampules675COMB002019-10-14
00858290006314Tooth Print Wafer Sample Pack660TPSAMP2019-05-30
00858290006598DenteShield Sample Opaque with Fluoride 685DSSAMP2020-06-11
00858290006529DenteShield Pit and Fissure Sealant Kit with Fluoride Clear685PITFTC2020-04-01
00858290006536DenteShield Pit and Fissure Sealant Kit with Fluoride Opaque685PITFTO2020-04-01

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
D2486300621TS1 Tongue Vacuum CleanerHAGER WORLDWIDE, INC.LCN2024-08-20
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