FDA.reportPublic FDA data

Henry Schein

Primary DI
H65890040891
Brand
Henry Schein
Company
HENRY SCHEIN, INC.
Model
9004089
Catalog number
9004089
Device description
Maxitab Tartar & Stain
Published
2019-05-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
H65890040891PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Denture cleanserAn agent 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, e.g., a toothbrush. It is normally available [non-prescription] over-the-counter (OTC) 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
012430880
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00845717012843AOJShenzhen AOJ Health Science & Technology Co., Ltd.JER2026-07-11
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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
D6919011103Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D6919011992Pro CleanPREMIER DENTAL PRODUCTS COMPANYJER2022-06-29
D746RB368C1RETAINER BRITE®DENTSPLY SIRONA ORTHODONTICS INC.JER2021-05-01