FDA.reportPublic FDA data

Printer Resin X-Ray Temporary (500g)

Primary DI
D800ZBAC6305RAY0
Brand
Printer Resin X-Ray Temporary (500g)
Company
ZIRKONZAHN SRL
Model
ZBAC6305RAY
Device description
Content: 1 bottle. Mass: 500g. Liquid resin intended for use with stereolithography (SLA) 3D printers, is a radiopaque resin used for manufacturing dental structures for intraoral try-in employed during the dental appointment.
Published
2026-05-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true

Product Codes#

Code, Name table
CodeName
JACSystem, X-Ray, Film Marking, Radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JACSystem, X-Ray, Film Marking, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800ZBAC6305RAY0PrimaryHIBCC0

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.

Regulatory Flags#

DUNS number
564251911
Device count
1
Premarket exempt
true
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

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