FDA.reportPublic FDA data

Printer Resin Bite Tray Blue (500g)

Primary DI
D800ZBAC6605BLU0
Brand
Printer Resin Bite Tray Blue (500g)
Company
ZIRKONZAHN SRL
Model
ZBAC6605BLU
Device description
Content: 1 bottle. Mass: 500g. Liquid resin intended for use with stereolithography (SLA) 3D printers, is used for manufacturing bite trays used to obtain impressions of a patient’s dentition.
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
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800ZBAC6605BLU0PrimaryHIBCC0

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
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
D080XXTRR05KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRR05KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXW050TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA10TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRRX1KGXXXA20TrinDy Try-InYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRT05KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXBLU0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
D080XXTRTX1KGXXPNK0TrinDy TrayYAMAHACHI DENTAL MFG.,CO.EBH2026-04-27
00197998216121Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216138Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216152Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216169Clarity™Solventum Orthodontics CorporationEBH2026-04-25
00197998216176Clarity™Solventum Orthodontics CorporationEBH2026-04-25
09359215000376DentaTRAY OrangeASIGA PTY LTDEBH2025-01-17
08800017902043Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
08800017902074Disposable Impression Bite TrayDXM CO., LTDEBH2024-06-11
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20386040012765COE®Gc America Inc.EBH2023-04-20
20386040012772COE®Gc America Inc.EBH2023-04-20
20386040012789COE®Gc America Inc.EBH2023-04-20
20386040012796COE®Gc America Inc.EBH2023-04-20
40386040001886COE®Gc America Inc.EBH2023-04-20