FDA.reportPublic FDA data

Pro Clean

Primary DI
00348783003833
Brand
Pro Clean
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9011102
Device description
PRO CLEAN STAIN CLEANER (CASE OF 10)
Published
2022-06-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00348783003833PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00348783003833003487830038333487830038330348783003833

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleanserAn agent intended to be used to remove soft debris from removable prosthetic dental appliances (e.g., dentures or bridges), normally by the immersion of the prosthesis/appliance in the agent overnight and/or mechanical cleaning with a toothbrush. It is intended for home-use and/or for hospitalized or institutionalized patients. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783010640Premier Jackson Original Tracheostomy Tube10343002026-06-09
00348783010657Premier Jackson Original Tracheostomy Tube10343102026-06-09
00348783010664Premier Jackson Original Tracheostomy Tube10343112026-06-09
00348783010671Premier Jackson Original Tracheostomy Tube10343122026-06-09
00348783010695Premier Jackson Original Tracheostomy Tube10343142026-06-09
00348783010701Premier Jackson Original Tracheostomy Tube10343152026-06-09
00348783010718Premier Jackson Original Tracheostomy Tube10343162026-06-09
00348783010725Premier Jackson Original Tracheostomy Tube10343172026-06-09
00348783010732Premier Jackson Original Tracheostomy Tube10343182026-06-09
00348783010749Premier Jackson Original Tracheostomy Tube10343192026-06-09
00348783010756Premier Jackson Original Tracheostomy Tube10343202026-06-09
00348783010770Premier Jackson Improved Tracheostomy Tube10346102026-06-09
00348783010787Premier Jackson Improved Tracheostomy Tube10346112026-06-09
00348783010794Premier Jackson Improved Tracheostomy Tube10346122026-06-09
00348783010800Premier Jackson Improved Tracheostomy Tube10346132026-06-09
00348783010817Premier Jackson Improved Tracheostomy Tube10346142026-06-09
00348783010824Premier Jackson Improved Tracheostomy Tube10346152026-06-09
00348783010831Premier Jackson Improved Tracheostomy Tube10346162026-06-09
00348783010848Premier Jackson Improved Tracheostomy Tube10346172026-06-09
00348783010855Premier Jackson Improved Tracheostomy Tube10346182026-06-09

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
D687215051CleanletsSultan Healthcare IncJER2022-11-30
00814832011093EFFDNT DENT BATH KIT 1CTMedtech Products Inc.JER2022-09-30
00348783003826Pro 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