FDA.reportPublic FDA data

SmileDirectClub Water Flosser - Black

Primary DI
00860012825585
Brand
SmileDirectClub Water Flosser - Black
Company
Ortho Dental Lab LLC
Model
150-0145
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
00860012825585PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012825585008600128255858600128255850860012825585

GMDN Terms#

Term, Definition table
TermDefinition
Water jet flosserAn electrically-powered device intended to provide a high-pressure water jet for dental flossing (removal of plaque and/or debris from between teeth) using a dedicated handpiece. It is normally available [non-prescription] over-the-counter (OTC) fo use in the home or healthcare facility.

Contacts#

Phone, Email table
PhoneEmail
1-855-604-7052support@smileset.com

Regulatory Flags#

DUNS number
119338749
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850078989369SmileSet Impression Kit - Retainer110-01032026-03-20
00850078989376SmileSet Impression Kit - Night Guard110-01022026-03-20
00850078989154SmileSet Premium Whitening Refill – 4 Pack150-01222025-09-25
00850078989161SmileSet Premium Whitening Sample Pen – 3 ml150-01232025-09-25
00850078989352SmileSet Cheek Retractor200-01192025-10-16
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus Light150-01412025-10-16
00860012825523SmileDirectClub Dissolving Strips130-01012025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus Light150-01422025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 Pack130-01022025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 Pack150-01432025-10-16
00860012825578SmileDirectClub Water Flosser - White150-01442025-10-16
00860014476143SmileSet Aligner/Retainer Seater/Removal Tool221-0100 2025-10-16
00850078989284SmileSet Premium Floss Picks Mint – 10 Pack Samples150-01352025-10-01
00850078989291SmileSet Premium Floss Picks Mint – 50 Pack150-01362025-10-01
00850078989321SmileSet Aligner/Retainer Seater/Removal Tool – 4 Pack221-01012025-10-01
00850078989109SmileSet Sonic Toothbrush Refill Heads - Black with Mint150-01212025-09-25
00850078989116SmileSet Sonic Toothbrush Refill Heads - White with Mint150-01182025-09-25
00850078989123SmileSet Premium Whitening Kit – Black150-01192025-09-25
00850078989130SmileSet Premium Whitening Kit – Mint150-01202025-09-25
00850078989147SmileSet Premium Whitening Kit – White150-01212025-09-25

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
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
10197344199761MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-03-06
00197344199771MEDLINEMEDLINE INDUSTRIES, INC.EFS2026-02-25
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
00073950338189Waterpik Cordless Gem 5100 Water FlosserWATER PIK, INC.EFS2026-02-03
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
10073950278192Water Pik Ultra Waterflosser (3pk)WATER PIK, INC.EFS2026-01-12