FDA.reportPublic FDA data

Usmile

Primary DI
00817277020989
Brand
Usmile
Company
Guangzhou Stars Pulse Co., Ltd.
Model
3000229
Device description
Y1 Sonic Electric Toothbrush
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JEQToothbrush, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JEQToothbrush, PoweredDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817277020989PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817277020989008172770209898172770209890817277020989

GMDN Terms#

Term, Definition table
TermDefinition
Basic electric toothbrushAn electrically-powered device designed to be used by a patient to brush clean their teeth and gums (i.e., remove plaque, tartar, stains). It typically consists of a proximal handle and an exchangeable distal head with rows of bristles (e.g., nylon) grouped in separate tufts or evenly distributed. The device provides automated bristle movement (e.g., rotary or vibratory) intended to augment brushing, and is typically used with toothpaste. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
554478113
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817277020910Usmile801300132025-11-17
00817277020934Usmile30000092025-11-17
00817277020965Usmile30001902025-11-17
00817277020972Usmile30002282025-11-17
00817277021061Usmile30002642025-11-17
00817277021085Usmile30003942025-11-17
00817277020927Usmile30000082025-10-05
00817277021054Usmile30002632025-10-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06938320799707SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799714SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799738SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799745SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-23
06938320799899SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799905SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799912SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799929SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799936SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799943SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799950SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799967SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799981SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
06938320799998SEAGONingbo Seago Electric Co.,Ltd.JEQ2026-10-12
05060640673731OrdoORDOCLUB LTDJEQ2026-09-22
05060640673748OrdoORDOCLUB LTDJEQ2026-09-22
05060640674097OrdoORDOCLUB LTDJEQ2026-09-22
05060640674141OrdoORDOCLUB LTDJEQ2026-09-22
05060640674486OrdoORDOCLUB LTDJEQ2026-09-22
00072239332290Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332511Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
00072239332528Dr. Brown'sDr. Brown's CompanyJEQ2026-06-05
05060640673717OrdoORDOCLUB LTDJEQ2026-05-29
05060640673830OrdoORDOCLUB LTDJEQ2026-05-29
05060640673953OrdoORDOCLUB LTDJEQ2026-05-29
05060640673960OrdoORDOCLUB LTDJEQ2026-05-29
05060640673991OrdoORDOCLUB LTDJEQ2026-05-29
05060640674004OrdoORDOCLUB LTDJEQ2026-05-29
05060640674011OrdoORDOCLUB LTDJEQ2026-05-29
05060640674035OrdoORDOCLUB LTDJEQ2026-05-29