FDA.reportPublic FDA data

Cleanlets

Primary DI
D687215051
Brand
Cleanlets
Company
Sultan Healthcare Inc
Model
21505
Catalog number
21505
Device description
Cleanlets Ultrasonic Tartar & Stain Cleaning Tablets
Published
2022-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JERCLEANER, DENTURE, MECHANICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JERCleaner, Denture, MechanicalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D687215051PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Medical device cleaning agentA substance (e.g., liquid, gel, foam, powder) with a neutral or alkaline pH intended to be applied to soiled medical, dental and/or surgical instruments/devices for pre-cleaning and/or cleaning to remove blood proteins and other organic compounds prior to disinfection or sterilization; it is not intended for in vitro diagnostic device use. It includes a detergent and may be added, as manufacturer specified, to water for cleaning and/or be applied directly to soiled devices immediately after their use as a pre-cleaning agent to prevent drying during transportation. Some types may include an enzyme(s) to facilitate cleaning. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Do not eat.
Special Storage Condition, Specify00Do not eat. In case of eye or skin contact, immediately flush with plenty of water.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056296981
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D6870031103FG1Durashield® CV0031103FG2016-09-23
D6870031104FG1Durashield® CV0031104FG2016-09-23
D6870031105FG1Durashield® CV0031105FG2016-09-23
D6870031106FG1Durashield® CV0031106FG2016-09-23
D6870020361SA1Com-Fit0020361SA2017-07-18
D687215001Cleanlets21500215002022-11-30
D687215201ReSURGE™ 21520215202022-12-05
D687AD320121Topex® AD32012AD320122022-12-05
D687AD33004FG13-WayAD33000FGAD33004FG2022-12-05
D687215200ReSURGE™ 21520215202022-12-05
D687215211ReSURGE™ 21521215212022-12-05
D687AD320120Topex® AD32012AD320122022-12-05
D687AD33004FG03-WayAD33000FGAD33004FG2022-12-05
D687AD320101Topex® AD32010AD320102022-12-03
D687AD320111Topex® AD32010AD320112022-12-03
D687AD320131Topex® AD32010AD320132022-12-03
D687AD321011Topex® AD32010AD321012022-12-03
D687AD321021Topex® AD32010AD321022022-12-03
D687AD321031Topex® AD32010AD321032022-12-03
D687AD33000FG13-WayAD33000FGAD33000FG2022-12-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D974BSIDLB1BritedentBright Supply, Inc.JER2024-03-12
D974BSIDLW1BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHB1BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHW1BritedentBright Supply, Inc.JER2024-03-12
D974BSIDLB2BritedentBright Supply, Inc.JER2024-03-12
D974BSIDLW0BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHB2BritedentBright Supply, Inc.JER2024-03-12
D974BSIRHW2BritedentBright Supply, Inc.JER2024-03-12
D974BSIDASST1BritedentBright Supply, Inc.JER2024-03-11
D974BSIRASST1BritedentBright Supply, Inc.JER2024-03-11
D974BSIDASST2BritedentBright Supply, Inc.JER2024-03-11
D974BSIRASST2BritedentBright Supply, Inc.JER2024-03-11
J009670010000SymproRenfert GmbHJER2023-07-10
D746RBUSC1Cordless Sonic CleanerDENTSPLY SIRONA ORTHODONTICS INC.JER2023-06-13
D746RBUSCC1Cordless Sonic CleanerDENTSPLY SIRONA ORTHODONTICS INC.JER2023-06-13
00814832011093EFFDNT DENT BATH KIT 1CTMedtech Products Inc.JER2022-09-30
00348783003826Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
00348783003833Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
00348783003840Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011102Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011103Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011992Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D746RB368C1RETAINER BRITE®DENTSPLY SIRONA ORTHODONTICS INC.JER2021-05-01
H65890040891Henry ScheinHENRY SCHEIN, INC.JER2019-05-15