FDA.reportPublic FDA data

SET ZZ BASE GC-AA-WSM N (White Scanmarker and screw)

Primary DI
D800ZBCD10631
Brand
SET ZZ BASE GC-AA-WSM N (White Scanmarker and screw)
Company
ZIRKONZAHN SRL
Model
ZBCD10631
Device description
Compatible with GC Tech. Aadva™ implants Set consisting of: 1x White Scanmarker 1x Abutment screw (for titanium base)
Published
2021-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
D800ZBCD10631PrimaryHIBCC0

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

Contacts#

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

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

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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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