FDA.reportPublic FDA data

help:ex plaque p, sample

Primary DI
J009670000010
Brand
help:ex plaque p, sample
Company
Renfert GmbH
Model
67000001
Catalog number
67000001
Device description
Cleanser for the removal of tartar and plaque on dental prostheses, Portioned with neutraliser, powder, sample
Published
2023-07-10
Public version status
New
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
NUXCleanser, Denture, Prescription

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUXCleanser, Denture, PrescriptionDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J009670000010PrimaryHIBCC0

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature41 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
328502976
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J00925620010000Dynamix Speed 2256200100025620010002023-07-10
J00927610010000DUOMIX II276100100027610010002023-07-10
J00927700010000PROMIX one277000100027700010002023-07-10
J009600010000SYMPRESS60001000600010002023-07-10
J009610010000SYMPRESS II61001000610010002023-07-10
J009660000000temp:ex66000000660000002023-07-10
J009670000000help:ex plaque p67000000670000002023-07-10
J009670001000help:ex plaque f67000100670001002023-07-10
J009670002000help:ex discolor f67000200670002002023-07-10
J009670010000Sympro67001000670010002023-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J009660000000temp:exRenfert GmbHNUX2023-07-10
J009670000000help:ex plaque pRenfert GmbHNUX2023-07-10
J009670001000help:ex plaque fRenfert GmbHNUX2023-07-10
J009670002000help:ex discolor fRenfert GmbHNUX2023-07-10