FDA.reportPublic FDA data

Pro Clean

Primary DI
D6919011103
Brand
Pro Clean
Company
PREMIER DENTAL PRODUCTS COMPANY
Model
9011103
Device description
PRO CLEAN STAIN CLEANER (SINGLE BOX)
Published
2022-06-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

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
D6919011103PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Instrument rinsing agentA liquid substance with a neutral or acidic pH intended for the rinsing of medical/surgical instruments (e.g., specula, forceps) after machine cleaning and prior to full sterilization. It is typically a phosphoric acid (H3PO4) in an aqueous solution that neutralizes the alkaline residues from detergents and water (acidic rinse), or lubricants and drying activators (neutral rinse) and may be added, as specified by the manufacturer, to an automated washer. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
014789663
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00348783000931MultiMatch30052012026-06-02
00348783000955MultiMatch30052022026-06-02
00348783000979MultiMatch30052102026-06-02
00348783000993MultiMatch30052112026-06-02
00348783001044MultiMatch30052122026-06-02
00348783001051MultiMatch30052992026-06-02
00348783000917MultiMatch30052002026-06-01
00348783011135Premier Decann Stopper10378162026-05-27
00348783011920Poli-Pro Disks20190992026-05-27
00348783011975Poli-Pro Disks20190752026-05-27
00348783011982Poli-Pro Disks20190762026-05-27
00348783011999Poli-Pro Disks20190772026-05-27
00348783012019Poli-Pro Disks20190792026-05-27
00348783011913Poli-Pro Disks20190702026-05-26
00348783011937Poli-Pro Disks20190712026-05-26
00348783011951Poli-Pro Disks20190732026-05-26
00348783006919Premier Scalers056332026-05-06
00348783006971Premier Scalers056922026-05-06
00348783006988Premier Scalers056942026-05-06
00348783006995Premier Scalers056952026-05-06

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
00348783003833Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
00348783003840Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011102Pro 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