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
10304040195472Essentials570582857058282026-09-04
10304040195489Essentials570582957058292026-09-04
10304040195038Criterion570581557058152026-07-29
10304040195045Criterion570581657058162026-07-29
10304040195052Criterion570581757058172026-07-29
10304040195069Criterion570581857058182026-07-29
10304040195076Criterion570582057058202026-07-29
10304040195083Criterion570581957058192026-07-29
10304040195090Criterion570582157058212026-07-29
10304040195106Criterion570582257058222026-07-29
00304040194416Henry Schein570572557057252026-07-20
00304040194423Henry Schein570572757057272026-07-20
00304040194430Henry Schein570572857057282026-07-20
00304040194447Henry Schein570572957057292026-07-20
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456201336JMUJMU DENTAL, INCJER2026-08-18
00840456201343JMUJMU DENTAL, INCJER2026-08-18
00840456201350JMUJMU DENTAL, INCJER2026-08-18
00840456201367JMUJMU DENTAL, INCJER2026-08-18
00840456201374JMUJMU DENTAL, INCJER2026-08-18
00840456201381JMUJMU DENTAL, INCJER2026-08-18
00840456201398JMUJMU DENTAL, INCJER2026-08-18
00840456201404JMUJMU DENTAL, INCJER2026-08-18
00840456201411JMUJMU DENTAL, INCJER2026-08-18
00840456216477JMUJMU DENTAL, INCJER2026-08-18
00840456216484JMUJMU DENTAL, INCJER2026-08-18
00840456216491JMUJMU DENTAL, INCJER2026-08-18
00840456223819JMUJMU DENTAL, INCJER2026-08-18
00840456223826JMUJMU DENTAL, INCJER2026-08-18
00840456223833JMUJMU DENTAL, INCJER2026-08-18
00840456223840JMUJMU DENTAL, INCJER2026-08-18
00840456223857JMUJMU DENTAL, INCJER2026-08-18
00840456223864JMUJMU DENTAL, INCJER2026-08-18
00840456223871JMUJMU DENTAL, INCJER2026-08-18
00840456223888JMUJMU DENTAL, INCJER2026-08-18
00840456223895JMUJMU DENTAL, INCJER2026-08-18
00840456223901JMUJMU DENTAL, INCJER2026-08-18
00840456223918JMUJMU DENTAL, INCJER2026-08-18
00840456223925JMUJMU DENTAL, INCJER2026-08-18
00840456223932JMUJMU DENTAL, INCJER2026-08-18
00840456223949JMUJMU DENTAL, INCJER2026-08-18
00840456223956JMUJMU DENTAL, INCJER2026-08-18
00840456223963JMUJMU DENTAL, INCJER2026-08-18
00840456223970JMUJMU DENTAL, INCJER2026-08-18
00840456223987JMUJMU DENTAL, INCJER2026-08-18