FDA.reportPublic FDA data

GenTek® Scanbody, External Hex, 3.4mmD

Primary DI
04251881769081
Brand
GenTek® Scanbody, External Hex, 3.4mmD
Company
Zfx GmbH
Model
ZFX05Z-ZB-EX-34
Published
2024-04-11
Public version status
Update
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
04251881769081PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251881769081042518817690814251881769081

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
1-800-342-5454dentalcs@zimvie.com

Regulatory Flags#

DUNS number
340880052
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04251881769005GenTek® Scanbody, Certain®, 3.4mmDZFX05Z-ZB-CE-342024-04-11
04251881769029GenTek® Scanbody, Certain®, 4.1mmDZFX05Z-ZB-CE-412024-04-11
04251881769043GenTek® Scanbody, Certain®, 5.0mmDZFX05Z-ZB-CE-502024-04-11
04251881769067GenTek® Scanbody, Certain®, 6.0mmDZFX05Z-ZB-CE-602024-04-11
04251881769104GenTek® Scanbody, External Hex, 4.1mmDZFX05Z-ZB-EX-412024-04-11
04251881769128GenTek® Scanbody, External Hex, 5.0mmDZFX05Z-ZB-EX-502024-04-11
04251881769142GenTek® Scanbody, External Hex, 6.0mmDZFX05Z-ZB-EX-602024-04-11
04251881769166GenTek® Scanbody, Eztetic®, 2.9mmDZFX05Z-ZB-EZ-292024-04-11
04251881769180GenTek® Scanbody, Low Profile, 4.8mmDZFX05Z-ZB-LP-482024-04-11
04251881769203GenTek® Scanbody, Tapered Abutment, 4.5mmDZFX05Z-ZB-TA-452024-04-11
04251881769227GenTek® Scanbody, TSV®/Trabecular Metal®, 3.5mmDZFX05Z-ZB-TSV-352024-04-11
04251881769241GenTek® Scanbody, TSV®/Trabecular Metal®, 4.5mmDZFX05Z-ZB-TSV-452024-04-11
04251881769265GenTek® Scanbody, TSV®/Trabecular Metal®, 5.7mmDZFX05Z-ZB-TSV-572024-04-11
04251881703504GenTek® Hexed Gold-Tite Screw, Certain®ZFX09-ZB-CE-HGTS2024-03-27
04251881703542GenTek® Large Gold-Tite Screw, Certain®ZFX09-ZB-CE-LGTS2024-03-27
04251881703627GenTek® Retaining Screw, Eztetic®ZFX09-ZB-EZ-RS2024-03-27
04251881703702GenTek® Retaining Screw, TSV®/Trabecular Metal®ZFX09-ZB-TSV-RS2024-03-27
04251881703740GenTek® Gold-Tite® Hexalobular Screw, Certain®, EngagingZFX09-ZB-CE-HLGTE2024-03-27
04251881703764GenTek® Gold-Tite® Hexalobular Screw, Certain®, Non-EngagingZFX09-ZB-CE-HLGTN2024-03-27
04251881703863GenTek® Hexalobular Retaining Screw, Eztetic®ZFX09-ZB-EZ-HLRS2024-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899995235299DRIVER HANDPIECE MINI ABUT. EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235305DRIVER HANDPIECE MINI ABUT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235312DRIVER HANDPIECE MINI ABUT. MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235329DRIVER RATCHET ABUT. HEX 2MM EXT. LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235343DRIVER RATCHET ABUT. HEX 2MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235367DRIVER RATCHET ABUT. HEX 2MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235374DRIVER RATCHET ABUT. HEX 2MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235381DRIVER RATCHET ABUT. HEX 2MM EXT. SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235503DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235510DRIVER RATCHET RETRIVER M1.8MM MEDIUMSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235527DRIVER RATCHET RETRIVER M1.8MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235534DRIVER RATCHET RETRIVER M1.6MM LONGSin Sistema de Implante Nacional S/ANDP2026-07-14
07899995235565DRIVER RATCHET RETRIVER M1.6MM SHORTSin Sistema de Implante Nacional S/ANDP2026-07-14
00815967026143RodinPac-Dent, Inc.NDP2026-07-13
00815967029403RodinPac-Dent, Inc.NDP2026-07-13
06942799000004SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000035SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000042SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000073SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000080SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
06942799000110SHINING 3D®Shining 3D Tech Co., Ltd.NDP2026-07-13
D990EK2A0Essentials Kit, 2 ArchSMART DENTURE CONVERSIONS, LLCNDP2026-07-13
07290109748054Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748061Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748078Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748085Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748092Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748108Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290109748115Bhi ImplantsBHI IMPLANTS LTDNDP2026-07-12
07290116660882Surgical ToolsCORTEX - DENTAL IMPLANTS INDUSTRIES LTDNDP2026-07-12