FDA.reportPublic FDA data

ZZ BASE MI-BT-WMSM-L12 3.4 - 4.0 (White Metal Scanmarker L12 with Scre

Primary DI
D800ZBED15132L12
Brand
ZZ BASE MI-BT-WMSM-L12 3.4 - 4.0 (White Metal Scanmarker L12 with Scre
Company
ZIRKONZAHN SRL
Model
ZBED15132L12
Device description
Compatible with Medical Instinct BoneTrust plus hex implants White Metal Scanmarker consisting of: 1x White Metal Scanmarker L12 1x White Metal Scanmarker Screw
Published
2021-09-27
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
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
D800ZBED15132L12PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, temporary, preformed, reusableA prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable 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

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290109748344Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07290109748351Bhi ImplantsBHI IMPLANTS LTDNDP2026-09-27
07899878068266NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068273NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068280NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
07899878068297NeodentJJGC Indústria e Comércio de Materiais Dentários S/A.NDP2026-09-25
D955BBCG35450Paul BandittTerlain Enterprises, Inc.NDP2026-09-25
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2023-10-19
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07392532001963Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001970Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001987Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14
07392532001994Astra Tech Implant System®Dentsply Implants Manufacturing GmbHNDP2022-07-14