FDA.reportPublic FDA data

FuturaJet Clear

Primary DI
ESDG6500151
Brand
FuturaJet Clear
Company
Schütz Dental GmbH
Model
650015
Device description
Cold-curing, methyl methacrylate resin intended specifically for injection moulding techniques (e.g. Unipress)
Published
2016-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESDG6500151PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius25 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315830349
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
ESDG6247391Tizian Ceramic Opaque Dentin A26247392016-09-08
ESDG6500101FuturaJet Pink Transparent6500102016-09-12
ESDG6500111FuturaJet Pink Transparent veined6500112016-09-12
ESDG6500121FuturaJet Pink Opaque6500122016-09-12
ESDG6500131FuturaJet Pink6500132016-09-12
ESDG6500141FuturaJet Pink veined6500142016-09-12
ESDG6500201FuturaJet Pink Transparent6500202016-09-12
ESDG6500211FuturaJet Pink Transparent Veined6500212016-09-12
ESDG6500221FuturaJet Pink Opaque6500222016-09-12
ESDG6500231FuturaJet Pink6500232016-09-12
ESDG6500241FuturaJet Pink veined6500242016-09-12
ESDG6500251FuturaJet Clear6500252016-09-12
ESDG6500501FuturaJet Pink Transparent6500502016-09-12
ESDG6500611FuturaJet Liquid6500612016-09-12
ESDG6500621FuturaJet Liquid6500622016-09-12
ESDG6501101FuturaPress LT Pink Transparent6501102016-09-12
ESDG6501111FuturaPress LT Pink Transparent veined6501112016-09-12
ESDG6501121FuturaPress LT Pink Opaque6501122016-09-12
ESDG6501131FuturaPress LT Pink6501132016-09-12
ESDG6501141FuturaPress LT Pink veined6501142016-09-12

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