FDA.reportPublic FDA data

GenTek® Scanbody, Certain®, 6.0mmD

Primary DI
04251881769067
Brand
GenTek® Scanbody, Certain®, 6.0mmD
Company
Zfx GmbH
Model
ZFX05Z-ZB-CE-60
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
04251881769067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251881769067042518817690674251881769067

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
04251881769081GenTek® Scanbody, External Hex, 3.4mmDZFX05Z-ZB-EX-342024-04-11
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
03701045246398KONTACTBIOTECH DENTALNDP2026-10-26
03701045279471KONTACTBIOTECH DENTALNDP2026-10-26
03701045279488KONTACTBIOTECH DENTALNDP2026-10-26
03701045279495KONTACTBIOTECH DENTALNDP2026-10-26
03701045279501KONTACTBIOTECH DENTALNDP2026-10-26
03701045279518KONTACTBIOTECH DENTALNDP2026-10-26
03701045279525KONTACTBIOTECH DENTALNDP2026-10-26
03701045279532KONTACTBIOTECH DENTALNDP2026-10-26
03701045279549KONTACTBIOTECH DENTALNDP2026-10-26
03701045279556KONTACTBIOTECH DENTALNDP2026-10-26
03701045279563KONTACTBIOTECH DENTALNDP2026-10-26
03701045279570KONTACTBIOTECH DENTALNDP2026-10-26
03701045279587KONTACTBIOTECH DENTALNDP2026-10-26
03701045279594KONTACTBIOTECH DENTALNDP2026-10-26
03701045279600KONTACTBIOTECH DENTALNDP2026-10-26
03701045279617KONTACTBIOTECH DENTALNDP2026-10-26
03701045279624KONTACTBIOTECH DENTALNDP2026-10-26
03701045279631KONTACTBIOTECH DENTALNDP2026-10-26
03701045279648KONTACTBIOTECH DENTALNDP2026-10-26
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