FDA.reportPublic FDA data

SmileDirectClub Dissolving Strips

Primary DI
00860012825523
Brand
SmileDirectClub Dissolving Strips
Company
Ortho Dental Lab LLC
Model
130-0101
Published
2025-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAUEraser, Dental Stain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAUEraser, Dental StainDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860012825523PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860012825523008600128255238600128255230860012825523

GMDN Terms#

Term, Definition table
TermDefinition
Teeth whitening kitA collection of devices intended to whiten natural teeth through bleaching. It typically includes a bleaching agent (e.g., a gel containing a low concentration of an oxidizing agent, such as carbamide peroxide or hydrogen peroxide), a syringe(s), a tray(s), a mouthguard, an applicator (e.g., a brush) and strips to apply/retain the bleaching agent to/on the teeth for a recommended period. This is a reusable device.

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
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
00860012825585SmileDirectClub Water Flosser - Black150-01452025-10-16
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
00860012825516SmileDirectClub Whitening Pen - 9 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825530SmileDirectClub Whitening Pen - 4 Pack Plus LightOrtho Dental Lab LLCMAU2025-10-16
00860012825547SmileDirectClub Whitening Refill - 8 PackOrtho Dental Lab LLCMAU2025-10-16
00860012825561SmileDirectClub Whitening plus Lip Balm - 4 PackOrtho Dental Lab LLCMAU2025-10-16
00850078989123SmileSet Premium Whitening Kit – BlackOrtho Dental Lab LLCMAU2025-09-25
00850078989130SmileSet Premium Whitening Kit – MintOrtho Dental Lab LLCMAU2025-09-25
00850078989147SmileSet Premium Whitening Kit – WhiteOrtho Dental Lab LLCMAU2025-09-25
00850078989154SmileSet Premium Whitening Refill – 4 PackOrtho Dental Lab LLCMAU2025-09-25
00850078989161SmileSet Premium Whitening Sample Pen – 3 mlOrtho Dental Lab LLCMAU2025-09-25
00850078989178SmileSet Premium Sensitive Whitening StripsOrtho Dental Lab LLCMAU2025-09-25
00353238006208Perio Sciences LED Tooth WhitenerPerio Sciences, LLCMAU2024-02-08
00353238106212Perio Sciences Replacement Tooth Whitening PensPerio Sciences, LLCMAU2024-02-08
06970016621824NonJiangxi Dentalbright Technology Co., LtdMAU2023-05-06
07506338301480MDC DentalMDC DENTALMAU2023-05-04
06970016623651DanielJiangxi Dentalbright Technology Co., LtdMAU2023-03-25
06970016621404GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621534GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621831GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016621879GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622005GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622807GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016622920GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623057GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623200GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016623293GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624030GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624481GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016624887GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016625006GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22
06970016625891GlorySmileJiangxi Dentalbright Technology Co., LtdMAU2023-02-22