FDA.reportPublic FDA data

Usmile

Primary DI
00817277021283
Brand
Usmile
Company
Guangzhou Stars Pulse Co., Ltd.
Model
USM057
Device description
D-lite OralCam
Published
2026-11-02
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
00817277021283PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817277021283008172770212838172770212830817277021283

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
00817277021238UsmileUSM5212026-11-02
00817277021245UsmileUSM5512026-11-02
00817277020910Usmile801300132025-11-17
00817277020934Usmile30000092025-11-17
00817277020965Usmile30001902025-11-17
00817277020972Usmile30002282025-11-17
00817277020989Usmile30002292025-11-17
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
00073950335515Waterpik Aquarius Water FlosserWATER PIK, INC.EFS2026-11-02
00073950349727Waterpik Aquarius Professional Water FlosserWATER PIK, INC.EFS2026-11-02
00817277021238UsmileGuangzhou Stars Pulse Co., Ltd.EFS2026-11-02
00817277021245UsmileGuangzhou Stars Pulse Co., Ltd.EFS2026-11-02
00073950343756Waterpik Cordless Advanced 7100 Water FlosserWATER PIK, INC.EFS2026-09-21
00073950343800Waterpik Cordless Advanced 7100 Water FlosserWATER PIK, INC.EFS2026-09-21
00073950348935Waterpik Cordless 1100 Water FlosserWATER PIK, INC.EFS2026-09-21
00073950348973Waterpik Cordless 1100 Water FlosserWATER PIK, INC.EFS2026-09-21
00073950346764Waterpik Cordless Pulse 3100 Water FlosserWATER PIK, INC.EFS2026-07-08
00073950341295Waterpik Cordless Pearl Water FlosserWATER PIK, INC.EFS2026-06-09
00073950345927Waterpik Cordless Enhance 3200 Water FlosserWATER PIK, INC.EFS2026-06-09
05060640673700OrdoORDOCLUB LTDEFS2026-05-29
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
08809260475687Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
08809260475694Oral irrigation unitSaeshin Precision Co., Ltd.EFS2026-05-21
00056310343412WaterPik Cordless Plus 5000 Water FlosserWATER PIK, INC.EFS2026-04-09
08052141311806Irrigation LineOMNIA SRLEFS2026-03-27
08052141312025Irrigation LineOMNIA SRLEFS2026-03-27
08052141312780Irrigation LineOMNIA SRLEFS2026-03-27
08052141312865Irrigation LineOMNIA SRLEFS2026-03-27
08052141312940Irrigation LineOMNIA SRLEFS2026-03-27
08052141313602Irrigation LineOMNIA SRLEFS2026-03-27
00073950255554Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
00073950338226Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
10073950255551Handle/Hose Assembly Repair KitWATER PIK, INC.EFS2026-03-13
10073950338223Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-03-13
00197344199764MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06