FDA.reportPublic FDA data

GenTek® TiBase, TSV®/TM® Engaging, 3.5mmD x 4.7mmH

Primary DI
04251881713824
Brand
GenTek® TiBase, TSV®/TM® Engaging, 3.5mmD x 4.7mmH
Company
Zfx GmbH
Model
ZFX11-ZB-TSV-3547-EL
Published
2024-03-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NHAAbutment, Implant, Dental, EndosseousDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231915000Zfx AbutmentsZfx GmbH - A Company of Zimvie2024-03-01NHA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04251881713824PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04251881713824042518817138244251881713824

GMDN Terms#

Term, Definition table
TermDefinition
Dental implant suprastructure, permanent, preformedA prefabricated device intended to provide a permanent intermediate fixture level between a dental implant and the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes one or more structural component(s) [e.g., abutment, ball, bar, bar overlay, coping, ring], and may be made of various materials [e.g., titanium (Ti), plastic, gold alloy]. It includes devices glued to prostheses and/or devices that can be replaced during cleaning cycles. An abutment screw(s) may be included, however the suprastructure does not represent the screw(s) in isolation. It may also be referred to as an abutment assembly or mesostructure.

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
088000968582488plant Implant System8dent Inc.NHA2026-10-28
088000968583238plant Implant System8dent Inc.NHA2026-10-28
088000968583308plant Implant System8dent Inc.NHA2026-10-28
088000968583548plant Implant System8dent Inc.NHA2026-10-28
088000968583618plant Implant System8dent Inc.NHA2026-10-28
088000968583928plant Implant System8dent Inc.NHA2026-10-28
088000968585218plant Implant System8dent Inc.NHA2026-10-28
088000968585388plant Implant System8dent Inc.NHA2026-10-28
088000968585458plant Implant System8dent Inc.NHA2026-10-28
088000968585698plant Implant System8dent Inc.NHA2026-10-28
088000968585768plant Implant System8dent Inc.NHA2026-10-28
088000968585838plant Implant System8dent Inc.NHA2026-10-28
088000968586068plant Implant System8dent Inc.NHA2026-10-28
088000968586138plant Implant System8dent Inc.NHA2026-10-28
088000968586208plant Implant System8dent Inc.NHA2026-10-28
088000968587508plant Implant System8dent Inc.NHA2026-10-28
088000968601668plant Implant System8dent Inc.NHA2026-10-28
088000968604018plant Implant System8dent Inc.NHA2026-10-28
088000968604258plant Implant System8dent Inc.NHA2026-10-28
088000968604328plant Implant System8dent Inc.NHA2026-10-28
088000968604568plant Implant System8dent Inc.NHA2026-10-28
088000968604638plant Implant System8dent Inc.NHA2026-10-28
088000968650488plant Implant System8dent Inc.NHA2026-10-28
088000968650558plant Implant System8dent Inc.NHA2026-10-28
088000968650628plant Implant System8dent Inc.NHA2026-10-28
08809984971922S-PlantIDIS CO.,LTDNHA2026-10-26
088000968514098plant Implant System8dent Inc.NHA2026-10-23
088000968514168plant Implant System8dent Inc.NHA2026-10-23
088000968514238plant Implant System8dent Inc.NHA2026-10-23
088000968515468plant Implant System8dent Inc.NHA2026-10-23