FDA.reportPublic FDA data

SmileSet Universal Cleaning Tablets – 90 pc

Primary DI
00850078989307
Brand
SmileSet Universal Cleaning Tablets – 90 pc
Company
Ortho Dental Lab LLC
Model
150-0137
Published
2025-09-25
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
EFTCleanser, Denture, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFTCleanser, Denture, Over The CounterDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850078989307PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850078989307008500789893078500789893070850078989307

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic appliance cleanserAn agent used to remove soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. It is normally used at home by the wearer of the appliance, and is typically supplied as tablets or crystals used to make a solution that removes and/or dissolves debris or accretions. This device may need to be used in conjunction with an electrical or mechanical cleansing device. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810051088649GuruNanda Aligner and Denture Cleaning FoamGurunanda, LLCEFT2026-04-29
00810194403972AiraAIRA, LLCEFT2026-01-16
10810194403979AiraAIRA, LLCEFT2026-01-16
00850078989314SmileSet Universal Cleaning Tablets - Sample 6pcOrtho Dental Lab LLCEFT2025-09-17
00616784487724WeCare Denture Cleanser, Antibacterial Dynarex CorporationEFT2025-09-01
00810180842273WeCare Denture Cleanser, Antibacterial Dynarex CorporationEFT2025-09-01
00855850008061SmilesaverSoluria II LLCEFT2024-06-19
00855850008078SmilesaverSoluria II LLCEFT2024-06-19
00855850008092Guard HealthSoluria II LLCEFT2024-06-19
00855850008108SmilesaverSoluria II LLCEFT2024-06-19
00364031300165SECURE Cleansing TabletsFITTYDENT INTERNATIONAL GmbHEFT2023-10-02
D832200451PlasdentPLASDENT CORPORATIONEFT2023-05-31
D832200450PlasdentPLASDENT CORPORATIONEFT2023-05-31
00665973010878DawnMistDukal LLCEFT2022-12-06
00665973010885DawnMistDukal LLCEFT2022-12-06
D784UZM30011UnipackUNIPACK MEDICAL CORPORATIONEFT2022-12-06
06943566100118Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
06943566107391Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
20665973010872DawnMistDukal LLCEFT2022-12-06
20665973010889DawnMistDukal LLCEFT2022-12-06
00816063021407Cleaning Crystals, PacketteAlign Technology, Inc.EFT2022-12-06
16943566100115Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
16943566107398Y-KelinANHUI GREENLAND BIOTECH CO.,LTDEFT2022-12-06
D784UZM30015UnipackUNIPACK MEDICAL CORPORATIONEFT2022-12-06
00814832015879EFFERDENT ORIGINAL 102CT TAB 6Medtech Products Inc.EFT2022-11-17
00814832015923EFFERDENT PM 90CT TAB 6Medtech Products Inc.EFT2022-11-17
10814832015876EFFERDENT ORIGINAL 102CT TAB 6MEDTECH PRODUCTS INC.EFT2022-11-17
10814832015920EFFERDENT PM 90CT TAB 6MEDTECH PRODUCTS INC.EFT2022-11-17
00814832015862EFFDNT ORIG 44CT TAB 6Medtech Products Inc.EFT2022-11-16
00814832015893EFFDNT PLUS MNT 44CT TAB 6Medtech Products Inc.EFT2022-11-16