FDA.reportPublic FDA data

VITA VIONIC® DENT RESIN A3,5 1000 g

Primary DI
EDET045891
Brand
VITA VIONIC® DENT RESIN A3,5 1000 g
Company
DETAX GmbH
Model
04589
Published
2026-02-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin
EBGCrown And Bridge, Temporary, Resin
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2
EBGCrown And Bridge, Temporary, ResinDental2
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EDET045891PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
343947949
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EDET035381luxaprint 3D shell UV beige 500 g035382022-10-25
EDET037171luxaprint 3D mould UV clear 500g037172022-10-25
EDET037181luxaprint 3D mould UV rose 500g037182022-10-25
EDET037471freeprint shell beige 1000 g037472022-10-25
EDET039191freeprint shell black 1000 g039192022-10-25
EDET039461luxaprint 3D mould UV rose orange 1000 g039462022-10-25
EDET039731luxaprint 3D mould UV light beige 1000 g039732022-10-25
EDET040731medicalprint shell, white, 1000 g040732022-10-25
EDET038421luxaprint 3D shell white 500g038422024-08-28
EDET042461luxaprint flex UV 500 g042462022-10-26
EDET047491FREEPRINT crown A3,5 500g047492026-04-13
EDET047511FREEPRINT crown A3,5 1000g047512026-04-13
EDET047081FREEPRINT crown A3,5 1000g047082026-02-04
EDET047091FREEPRINT crown A3,5 500g047092026-02-04
EDET047541dx retainer 5 kg047542026-03-06
EDET047551dx retainer 1000g047552026-03-06
EDET030161medicalprint shell beige 2.0 1000g030162026-02-25
EDET042611Ultraprint-Dental Gingiva UV 1000g042612022-10-14
EDET045881VITA VIONIC® DENT RESIN A3,5 500 g045882026-02-04
EDET046341VITA VIONIC® BASE RESIN FLEX pink transparent 1000g046342026-02-04

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Primary DI, Brand, Company table
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