FDA.reportPublic FDA data

Temp Premium Flexible

Primary DI
D800TMAE3321
Brand
Temp Premium Flexible
Company
ZIRKONZAHN SRL
Model
TMAE3321
Device description
Temp Premium Flexible A3-B3 98H21
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
D800TMAE3321PrimaryHIBCC0

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
D800FMAA01030Colour Liquid A1 (20 ml)FMAA01032026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)FMAA04032026-05-28
D800FMAA05030Colour Liquid A4 (20 ml)FMAA05032026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)FMAA06032026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)FMAA07032026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)FMAA08032026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)FMAA09032026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)FMAA10032026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)FMAA11032026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)FMAA12032026-05-28
D800FMAA13030Colour Liquid C4 (20 ml)FMAA13032026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)FMAA14032026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)FMAA15032026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)FMAA16032026-05-28
D800FMAA17030Set Colour Liquid (20 ml)FMAA17032026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)FMAA19032026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)FMAA20032026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)FMAA31022026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)FMAA31032026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)FMAA32022026-05-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
EPOLPMFLAG5600PMMA CAD/CAM discPOLIDENT d.o.o.EBG2025-05-13
EPOLPMMA1270PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1350PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA1430PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-08
EPOLPMMA0230PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0310PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0390PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0470PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0550PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0630PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0710PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0790PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0870PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0950PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-07
EPOLPMMA0070PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1030PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1110PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLPMMA1190PMMA CAD/CAM discPOLIDENT d.o.o.EBG2024-10-04
EPOLKML200160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML200200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML201200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML202200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML203200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML204200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205160DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02
EPOLKML205200DD poly Y MLPOLIDENT d.o.o.EBG2024-10-02