FDA.reportPublic FDA data

temp:ex

Primary DI
J009660000000
Brand
temp:ex
Company
Renfert GmbH
Model
66000000
Catalog number
66000000
Device description
Cleanser for dissolving temporary cement from dental restorations, liquid
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
J009660000000PrimaryHIBCC0

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
J009670000000help:ex plaque p67000000670000002023-07-10
J009670000010help:ex plaque p, sample67000001670000012023-07-10
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
J009670000000help:ex plaque pRenfert GmbHNUX2023-07-10
J009670000010help:ex plaque p, sampleRenfert GmbHNUX2023-07-10
J009670001000help:ex plaque fRenfert GmbHNUX2023-07-10
J009670002000help:ex discolor fRenfert GmbHNUX2023-07-10