FDA.reportPublic FDA data

Usmile

Primary DI
00817277021085
Brand
Usmile
Company
Guangzhou Stars Pulse Co., Ltd.
Model
3000394
Device description
Usmile C10 Portable Dental Flosser
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
EFSUnit, Oral Irrigation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFSUnit, Oral IrrigationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817277021085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817277021085008172770210858172770210850817277021085

GMDN Terms#

Term, Definition table
TermDefinition
Oral lavage systemAn assembly of devices intended for automated or semi-automated irrigation and washing of tissue/debris from teeth, gums, and other parts of the oral cavity (e.g., tongue) through application of pulsed jets of non-medicated liquids (e.g., mouthwash, water), to maintain oral hygiene; it may in addition be intended for nasal lavage. It consists of a central mains electricity (AC-powered) unit with a reservoir and pump, and a number of hand-held applicators, each typically designed to clean a specific oral anatomy (e.g., tongue, braces, gum line). It is normally available [non-prescription] over-the-counter (OTC) for use in the home and dental office.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554478113
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817277020910Usmile801300132025-11-17
00817277020934Usmile30000092025-11-17
00817277020965Usmile30001902025-11-17
00817277020972Usmile30002282025-11-17
00817277020989Usmile30002292025-11-17
00817277021061Usmile30002642025-11-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00073950345897Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346122Waterpik Cordless Water FlosserWATER PIK, INC.EFS2026-05-26
00073950346788Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-05-26
00073950347167Waterpik Cordless 1200 Water FlosserWATER PIK, INC.EFS2026-05-26
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
10197344199778MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
00050428005408CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005415CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
00050428005422CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDEFS2026-02-13
05060640672406OrdoORDOCLUB LTDEFS2026-02-06
00100739503381Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
00056310343870Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
00056310343900Waterpik Cordless 1000 Water Flosser (2pk)WATER PIK, INC.EFS2026-01-28
00073950343589WaterPik Ultra Plus and Cordless Express Water Flosser ComboWATER PIK, INC.EFS2026-01-08
00073950038232WaterPik Cordless Select 5100 Water FlosserWATER PIK, INC.EFS2026-01-05
00073950342360WaterPik Cordless Plus 5000 Water Flosser (2PK)WATER PIK, INC.EFS2026-01-05
00073950342438WaterPik Cordless Advanced 2.0 Water Flosser (6PK)WATER PIK, INC.EFS2026-01-05
00073950342773WaterPik Cordless 1100 Water Flosser (6 PK)WATER PIK, INC.EFS2026-01-05
00073950000185WaterPik Promax WaterflosserWATER PIK, INC.EFS2025-12-09
10073950337240WaterPik Promax Waterflosser 6PKWATER PIK, INC.EFS2025-12-09
06976344070150ABOBOMiley Technology (Hebei) Co., LTDEFS2025-11-20
00817277020934UsmileGuangzhou Stars Pulse Co., Ltd.EFS2025-11-17
00860014476112SmileSet Premium Handheld Water Flosser – BlackOrtho Dental Lab LLCEFS2025-09-25
00860014476129SmileSet Premium Handheld Water Flosser – MintOrtho Dental Lab LLCEFS2025-09-25
00850078989000SmileSet WF500 Water Flosser – WhiteOrtho Dental Lab LLCEFS2025-09-17
00850078989024SmileSet Water Flosser Replacement Tips - 4 packOrtho Dental Lab LLCEFS2025-09-17
06926347961061eclat essenceShenzhen Brav Electronic Technologies Co., Ltd.EFS2025-07-10
06926347961078eclat essenceShenzhen Brav Electronic Technologies Co., Ltd.EFS2025-07-10