FDA.reportPublic FDA data

Dale Scrape-n-Suction Tongue Cleaner

Primary DI
00817612021008
Brand
Dale Scrape-n-Suction Tongue Cleaner
Company
Dale Medical Products, Inc.
Model
220
Catalog number
220
Device description
The Dale Scrape-n-Suction Tongue Cleaner is a plastic device with a hollow core that allows it to be attached to a vacuum source to remove biofilm from the tongue.
Published
2024-12-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
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
00817612021015PackageGS150In Commercial Distribution
00817612021008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817612021015008176120210158176120210150817612021015
00817612021008008176120210088176120210080817612021008

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
001061233
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
H84101501Dale Foley Catheter Holder1501502018-08-30
H84103161Dale Foley Catheter Holder3163162018-08-30
H84103301Dale Foley Catheter Holder3303302018-08-30
H84104901Dale Urodynamic Tube Holder4904902018-08-30
00817612020001Dale General Purpose Securement Device9529522018-09-10
00817612020025Dale Catheter Securement Device8538532018-09-10
00817612020124Dale Catheter Securement Device8508502018-09-10
00817612020148Dale Catheter Securement Device8518512018-09-10
00817612020162Dale Catheter Securement Device8528522018-09-10
00817612020186Dale Catheter Securement Device8548542018-09-10
00817612020209Dale General Purpose Securement Device9509502018-09-10
00817612020223Dale General Purpose Securement Device9519512018-09-10
00817612020902Dale Catheter Securement Device8498492018-09-10
00817612020926Dale Catheter Securement Device8488482018-10-10
00817612021107Dale IV Line Manager6306302025-08-11
00817612020544Dale Foley Catheter Holder1501502019-03-18
00817612020568Dale Foley Catheter Holder3163162019-03-18
00817612020582Dale Foley Catheter Holder3303302019-03-18
00817612021121Dale Airway Holder2602602026-03-11
00817612021114Dale IV Line Manager6306302025-08-11

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
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
00817612021015Dale Strapless Bendable ArmboardDALE MEDICAL PRODUCTS, INC.LCN2020-09-14