FDA.reportPublic FDA data

Philips Sonicare BreathRx

Primary DI
00075020048066
Brand
Philips Sonicare BreathRx
Company
Discus Dental, LLC
Model
DIS359/11
Published
2020-08-28
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
00075020048066PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00075020048066000750200480660750200480660075020048066

GMDN Terms#

Term, Definition table
TermDefinition
Tongue scraper, reusableA device used 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 copper (Cu) because of its biostatic properties (i.e., bacteria will not grow on its surface), and has a scraping ridge that is manually pulled over the surface of the tongue. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
831726109
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08710103611967Philips Zoom! Protective EyewearDIS2038810203303002020-09-20
00075020035011Philips Zoom! WhiteSpeed Whitening LED AcceleratorDIS5588810558015402020-09-23
08710103632085Philips Zoom! WhiteSpeed IsoPrep RetractorDIS5738810573010202020-08-28
08710103632092Philips Zoom! IsoPrep RetractorDIS5748810574010202020-08-28
08710103632061Philips Zoom! Chairside Light-Activated Whitening KitDIS57148810571010202019-06-21
00075020035004Philips Zoom! Chairside Light-Activated Whitening KitDIS5578810557015402016-09-07
00075020043863Philips Relief ACP Oral Care GelDIS2728810272305402016-09-07
00075020065469Philips Zoom! Relief ACP Oral Care GelDIS4558810455015402016-09-07
00075020034991Philips Zoom! Chairside Light-Activated Whitening KitDIS5568810556015402016-09-07
00075020043900Relief ACPDIS445/012016-09-07
00075020044129Philips ZoomDIS716/012020-08-28
00075020089892Relief ACPDIS571/992019-09-24
08710103632122Philips ZoomDIS578/012020-09-23
00075020034311DASHDIS429/012016-09-07
00075020034403Relief ACPDIS455/022016-09-07
00075020034236Philips Sonicare BreathRxDIS442/012020-08-28
00075020034243Philips Sonicare BreathRxDIS442/022020-08-28
00075020048004Philips Sonicare BreathRxDIS251/012020-08-28
00075020048035Philips Sonicare BreathRxDIS357/032020-08-28
00075020048042Philips Sonicare BreathRxDIS357/112020-08-28

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