FDA.reportPublic FDA data

Abro Basic Mono B3 106H28

Primary DI
D800DSAL10628B030
Brand
Abro Basic Mono B3 106H28
Company
ZIRKONZAHN SRL
Model
DSAL10628B03
Device description
Content: 1 piece Height: 28 mm Resin with improved translucency, flexural strength as well as fracture and abrasion resistance. Specifically designed for the production of denture teeth, long-term temporaries as well as secondary and tertiary structures.
Published
2023-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800DSAL10628B030PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
+390474066660info@zirkonzahn.com

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
D800ZBAC6105TRA0Printer Resin Surgical Guide Transpa (500g)ZBAC6105TRA2026-05-20
D800ZBAC6305RAY0Printer Resin X-Ray Temporary (500g)ZBAC6305RAY2026-05-20
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZBAC6405A012026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZBAC6405A022026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZBAC6405A032026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZBAC6405A042026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZBAC6405A352026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZBAC6405B012026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZBAC6405B022026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZBAC6405B032026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZBAC6405B042026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZBAC6405BLE2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZBAC6405C012026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZBAC6405C022026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZBAC6405C032026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZBAC6405C042026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZBAC6405D022026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZBAC6405D032026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZBAC6405D042026-05-20
D800ZBAC6505TIA0Printer Resin Denture Base Temporary A (500g)ZBAC6505TIA2026-05-20

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