FDA.reportPublic FDA data

SET ZZ BASE BT-MIM-WSM 5.5

Primary DI
D800ZBCD3332
Brand
SET ZZ BASE BT-MIM-WSM 5.5
Company
ZIRKONZAHN SRL
Model
ZBCD3332
Device description
SET ZZ BASE BT-MIM-WSM 5.5 (White Scanmarker and screw).The ZZ BASE WSM (WHITE SCANMARKER) allows the user to record the implant position and inclination in the patient’s mouth or on the model.
Published
2020-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D800ZBCD3332PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant abutment analog, scanningA non-sterile device intended to be used as temporary copy of a dental implant abutment in a patient to confirm the position of the final dental implant body during dental implant restorative procedures. It is used during a scanning procedure, typically performed with a digital intraoral sensor (e.g., via x-ray imaging). It consists of a rod-like device intended to be attached to a dental implant; it is typically made of a radiopaque material (e.g., barium sulfate). This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
564251911
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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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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