FDA.reportPublic FDA data

Temp Premium

Primary DI
D800TMAB0108
Brand
Temp Premium
Company
ZIRKONZAHN SRL
Model
TMAB0108
Device description
Temp Premium A1-B1 95H08
Published
2018-07-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin
POWCrown And Bridge, Long-Term Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2
POWCrown And Bridge, Long-Term Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800TMAB0108PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
564251911
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D800ZRTA09010Prettau 5 98H10ZRTA09012026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZRTA09112026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZRTA09212026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZRTA09312026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZRTA09412026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZRTA09512026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZRTA09622026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZRTA09712026-09-18
D800ZRTA106100Prettau 5 106H10ZRTA106102026-09-18
D800ZRTA106110Prettau 5 106H11ZRTA106112026-09-18
D800ZRTA106120Prettau 5 106H12ZRTA106122026-09-18
D800ZRTA106130Prettau 5 106H13ZRTA106132026-09-18
D800ZRTA106140Prettau 5 106H14ZRTA106142026-09-18
D800ZRTA106150Prettau 5 106H15ZRTA106152026-09-18
D800ZRTA106160Prettau 5 106H16ZRTA106162026-09-18
D800ZRTA106170Prettau 5 106H17ZRTA106172026-09-18
D800ZRTA106180Prettau 5 106H18ZRTA106182026-09-18
D800ZRTA106190Prettau 5 106H19ZRTA106192026-09-18
D800ZRTA106200Prettau 5 106H20ZRTA106202026-09-18
D800ZRTA106210Prettau 5 106H21ZRTA106212026-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
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