FDA.reportPublic FDA data

Tizian Ceramic Dentin A3.5

Primary DI
ESDG6247661
Brand
Tizian Ceramic Dentin A3.5
Company
Schütz Dental GmbH
Model
624766
Device description
Dental glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials.
Published
2016-09-08
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
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
ESDG6247661PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature12 Degrees Celsius38 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
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
ESDG6500151FuturaJet Clear6500152016-09-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA17030Set Colour Liquid (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33020Colour Liquid Prettau A3 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33030Colour Liquid Prettau A3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34020Colour Liquid Prettau A3,5 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34030Colour Liquid Prettau A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35020Colour Liquid Prettau A4 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35030Colour Liquid Prettau A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36020Colour Liquid Prettau B1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36030Colour Liquid Prettau B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA37020Colour Liquid Prettau B2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28